Investigators:
Professor Jayashri Kulkarni
Mr Anthony de Castella
Ms Suzette Sheppard
In this recently completed study we investigated the "estrogen-protection' hypothesis, which suggests that estrogen may provide "protection" against early onset of severe schizophrenia in women, thereby accounting for increased vulnerability during both lifetime and monthly low estrogen phases. In this double blind controlled trial we compared changes in psychopathology and cognition between one group of women receiving standard antipsychotic treatment and a placebo, and a second matched group receiving standard antipsychotic treatment plus low dose (100mcg) estradiol patches.
After each participant provided informed consent, it was established that the participant met the inclusion criteria for the trial.
Inclusion criteria:
Female patients who:
- are of potential child bearing age
- have a current diagnosis of Schizophrenia, Schizophreniform disorder, or Schizoaffective disorder according to DSM-IV criteria
- have a total score of at least 60 on the PANSS - Positive and Negative Symptom Scale
- are able to give informed consent
Exclusion criteria:
Female patients who:
- are pregnant or lactating
- have postpartum psychosis or related disorder
- have known abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, or other serious medical conditions that would contraindicate estrogen use
- are already taking estrogen preparations such as the oral contraceptive pillare post-menopausal or pre-menarche
- have a psychotic illness due to illicit drugs or who have a history of substance abuse or dependence during the last 6 months
Women were then randomised to either the estrogen or placebo group. Women are seen weekly over a 28 day period, in which time cognitive batteries and a range of psychopathology assessment tools are administered. Blood was taken at each visit for recording of hormonal levels. Changes in medications, social and physical circumstances were also documented.
Currently data is being analysed for this study and results should be published soon.
In the second half of 2006, we will be undertaking a new multi-site estrogen trial. A target number of 175 patients (75 from The Alfred, 50 from Geelong Hospital and 50 from Dandenong Hospital) will be recruited over a three-year period. This trial will be run in a similar manner to the 100mcg adjunctive estrogen trial however will run for a total of eight weeks as opposed to four weeks. Additionally it will be a three-arm trial instead of a two-arm trial and compare the dose of 200mcg estrogen in addition to 100mcg estrogen versus a placebo. Equal numbers of participants will be assigned to each group. Using the higher dose of estrogen will allow us to determine whether there is any benefit of using a dose of 200mcg as opposed to 100mcg estrogen on the general psychopathology scores or cognitive tests of participants. Follow up visits will be similar to the 100mcg trial with similar psychopathology and cognitive batteries conducted over the eight week period. We hope to start recruiting participants for this exciting study soon.
To date, we have conducted an open label pilot study (Kulkarni J, et al, 1996), and subsequent to this a dose-finding study for the optimal use of estradiol in women with schizophrenia (Kulkarni J, et al 2001). In the pilot study 11 women of child-bearing age with schizophrenia were given 0.02 mg of oral ethynyl estradiol as an adjunct to antipsychotic drug treatment for 8 weeks, and compared their progress with a similar group who received antipsychotic drugs only. The group receiving estrogen made a significantly more rapid recovery from acute psychotic symptoms and also reported improvement in their general health status.
The dose finding study was a 3 arm double blind placebo controlled 28 day study in which 12 women received 50mcg transdermal estradiol plus standardised antipsychotic drugs, 12 women received 100mcg transdermal estradiol plus antipsychotic drugs, and 12 women received placebo plus standardised antipsychotic drugs. The main finding from this study was that the addition of 100mcg estradiol provided the best outcome for women with schizophrenia compared with a group who received 50mcg transdermal estradiol and a group who received antipsychotic drugs alone. The clinical improvement was significantly greater in the adjunctive 100mcg estrogen group with respect to key psychotic symptoms.
Investigators:
Professor Jayashri Kulkarni
Mr Anthony de Castella
Ms Suzette Sheppard
Ms Heather Gilbert
This study is a 12-week, three-arm, double blind, placebo-controlled study in the treatment of acute schizophrenia in postmenopausal women, and builds on the successful work Professor Kulkarni has completed exploring the potential benefits of estrogen therapy in treating schizophrenia.
Once women have provided informed consent to participate in the trial it is important that they meet the inclusion criteria before beginning the trial.
Inclusion criteria:
Female patients who:
- are postmenopausal and over 45 years of age
- have a current diagnosis of Schizophrenia, Schizophreniform disorder or Schizoaffective disorder according to DSM-IV criteria
- are not currently taking a mood stabiliser
- are not currently on Hormone Replacement Therapy
- have no current substance abuse issues
- have no significant unstable medical illness
- are able to give informed consent
Women are then randomly assigned to take one tablet of either Raloxifene hydrochoride (SERM- also known as a "brain estrogen"), continuous hormone replacement therapy (conjugated estrogen / progestin) or a placebo every day for 12 weeks.
It is hypothesised that the women receiving adjunctive Raloxifene will have a quicker recovery from psychotic symptoms, as measured on psychopathology rating scales, compared with the women receiving adjunctive HRT or adjunctive placebo. The use of both Raloxifene or HRT for 12 weeks is very safe and the recent Australian data strongly supports this (TGA guidelines 2002). It is important to note that Raloxifene does not adversely affect reproductive organs such as breast or uterine tissue.
During the study, general psychopathology tests will be conducted weekly and cognitive function testing will be carried out monthly. Hormone levels, weight, and possible extra-pyramidal side effects will also be monitored closely over the 12-week period.
Research has indicated that there are several reasons why Raloxifene could prove useful in assisting recovery from psychotic symptoms in postmenopausal women.
- Life cycle studies have shown that women are more vulnerable for either a first episode of psychosis or relapse of existing illness at two major periods of hormonal change; firstly during the postpartum period and secondly during the menopause (Seeman, 1986; 1996).
- This is supported by case reports that have focused on women whose schizophrenia symptoms were exacerbated at low estrogen phases of the menstrual cycle (Endo, 1978). While a study conducted by Reicher-Rossler and colleagues (1994) demonstrated that psychotic symptoms in a group of 32 women with schizophrenia, improved during the high estrogen phase of their menstrual cycle.
- Several studies by Kulkarni et al. (1996, 2000, 2001) have shown that premenopausal women with schizophrenia who were given estradiol as an adjunct to antipsychotic drug treatment, made a significantly more rapid recovery from acute psychotic symptoms and also reported improvement in their general health status, compared with a similar group who received antipsychotic drugs only.
- With the recent advent of selective estrogen receptor modulators, in particular Raloxifene hydrochloride, there is the potential to harness the positive estrogenic effect on CNS neurotransmitter systems without affecting breast or uterine tissue. A study (Nickleisen et al 1999) on the effect of Raloxifene on cognition in healthy, postmenopausal women found a slight increase in verbal memory performance after one month of high dose treatment, while no other differences were found after 12 months of treatment.
A recently published paper (Yaffe et al 2005) showed that at a dose of 120mg/day, Raloxifene could reduce the risk of cognitive impairment in post menopausal women. We are currently looking at modifying the current protocol to include a 120mg/day dose of Raloxifene as it is anticipated that the cognitive benefits could be more pronounced using this dose as opposed to 60mg. At this point, there are no clinical studies investigating the effect of Raloxifene on psychotic symptoms.
Investigators:
Professor Jayashri Kulkarni
Anthony de Castella
Barbara Headey
Objective of the study:
To investigate the effect of adding 2mg oral estradiol valerate (estrogen) to standardised antipsychotic drug treatment in a group of men with schizophrenia, for two weeks.
Background to the study:
Estrogen has been shown to modulate both the dopamine and serotonin neurotransmitter systems - the main neurotransmitters implicated in the pathogenesis of schizophrenia. Data from clinical studies suggest that estrogen significantly enhanced the treatment of acute severe psychotic symptoms in women with schizophrenia. This led to the hypothesis that estrogen may improve recovery time for men with schizophrenia by improving their response to neuroleptics. A pilot study completed in 1999 supported this hypothesis and led to the present study.
Hypothesis of the study:
That men receiving adjunctive estradiol will have a quicker recover from psychotic symptoms compared with those receiving a placebo.
Selection criteria:
We are looking for clients who are:
- male in- or outpatients with a diagnosis of Schizophreniform, Schizophrenia or Schizoaffective disorder
- endocrinologically and physically well
- aged 18 and over
- acutely psychotic
Design of the study:
The study is a two-week double blind trial. Clients will be randomised to receive either estradiol or placebo in a 1:1 ratio during the two-week double blind phase. Each client will be allocated an identification number and will be randomly assigned to a treatment regimen according to a computer generated pseudo-random code.
Concomitant treatments:
All clients will participate in standard psychosocial therapies and activities as advised by their treatment team. Wherever possible the antipsychotic drugs to be used during the trial will be Risperidone or Olanzapine at a maximum dose of 4mg oral/day for Risperidone and 4mg Risperidone equivalence for Olanzapine. However if clinically indicated, participants may be on higher doses. Patients on other antipsychotic treatments will also be accepted for the study.
Assessments performed:
Ratings of symptoms, cognitive tests, blood tests, and extrapyramidal side effects will be monitored.
Use of estradiol in men:
This study involves the use of very low dose oral estradiol over a two-week period only. At this dosage and duration, estradiol has not been found to have adverse effects on men. Clients will be closely monitored for adverse effects and can be withdrawn at any stage.
Investigators:
Professor Jayashri Kulkarni
Peter Goh
P Fitzgerald
Toni Scaffidi
Anthony de Castella
Funded by an investigator initiated research grant from Eli Lilly, this project aims to examine the effect of treatment with olanzapine and risperidone on the Hypothalamo-Pituitary Gonadal axis in women. Women have been largely excluded from clinical trials of new medication, mainly because of the difficulties associated with menstrual cycle variables. However, in our studies we have found that women have different needs to men in regard to treatment with psychotropic medication. Endocrine disturbances, such as menstrual irregularities, altered libido, infertility and weight gain, are a side effect of neuroleptic treatment and are thought to be due to the elevated prolactin levels induced by neuroleptic treatment. Prolactin has been reported as having an inhibitory effect on estrogen output from the ovaries which may be the cause of the observed menstrual disturbances in women undergoing neuroleptic treatment. Another consideration is that long term disruption of the hormonal balance can cause a reduction in bone mineral density, which may lead to osteoporosis.
The aim of this study is to compare the effects of two atypical neuroleptics, Olanzapine and Risperidone in women with schizophrenia or related disorders. The project will explore neuroendocrine disturbances related to this treatment and their effect on the reproductive functioning of women with schizophrenia.
Twenty five women were recruited to receive either Olanzapine or Risperidone for a three month period. Interviews were conducted on a fortnightly basis and include questions in regards to psychopathology, menstrual cycle, adverse events, mood and sexual functioning. A blood sample taken at each visit measured hormone levels. In addition, bone density measurements were performed at the beginning and end of study to determine whether there were any changes evident after three months of treatment with Olanzapine or Risperidone.
Preliminary results show that women taking Risperidone have significantly higher prolactin levels than those on olanzapine and lower estrogen values (not significant). Interestingly, it was also found that subject's weight and BMI were higher in the Risperidone group. Further analysis will be performed on the full sample to confirm these results.
Investigators:
Professor Jayashri Kulkarni
Henry Burger
Anthony de Castella
Paul Fitzgerald
Mood stabilizers such as Lithium and Sodium Valproate appear to have their anti-manic effect by targeting protein kinase C (PKC) isozymes. It has been hypothesized that PKC inhibitors such as anti-estrogen agents may represent a novel class of therapeutic agents for the treatment of bipolar disorder. Preliminary studies suggest the use of anti-estrogens in the treatment of mania. In our work, using adjunctive estrogen in women with psychosis, we found that four women with bipolar manic illness who received 50mcg of adjunctive transdermal estrogen for 28 days, worsened with respect to positive psychotic symptoms compared with 12 women with schizophrenia who improved with adjunctive estrogen.
Twenty-one females with a current diagnosis of bipolar disorder - manic phase will be recruited over an 18 month period. Each patient will be randomized into one of three groups. One group will receive adjunctive Tamoxifen at 40mg/day, the second group will receive Progesterone 20mg/day and the final group will receive a placebo. Each group will also receive Lithium Carbonate at a dose to achieve a blood level of 0.8 mmol/L. The study is of a double-blind nature so neither the patient nor the interviewer will be aware of the treatment group assigned.
The study is of 28 days duration with interviews conducted on a weekly basis. At each interview, data regarding symptomatology, mood, adverse events and menstrual cycle functioning will be recorded. In addition, a blood sample will be taken at each visit to measure hormone levels and serum lithium levels.
Inclusion criteria:
- DSM-IV diagnosis of Bipolar affective disorder or Schizoaffective disorder
- Currently experiencing symptoms of either elevated mood, hypomania or mania
- No other clinically significant concomitant medical or neurological illness
Investigators:
Cali Bartholomeusz
Pradeep Nathan
Professor Jayashri Kulkarni
Background of study:
Since the emergence of cognitive symptoms as an independent and unequivocal feature in schizophrenia, the need for effective treatment in alleviating cognitive deficits has become much sought after. Understanding the effect of estrogen on cognitive processes, such as memory, learning and attention, which are modulated by the cholinergic system, may have valuable implication for the use of estrogen in the treatment of cognitive deficits seen in schizophrenia. Although research has shown that estrogen does have an effect on certain domains of cognition the mechanisms of action are still unknown. Given that the cholinergic system has long been associated with memory, learning and attention it is proposed that estrogen's effects on cognition may be modulated by the cholinergic system.
Objective of study:
To examine the effects of estrogen on cognitive performance in healthy pre-and post-menopausal women and to determine whether estrogen's effects on cognition are mediated by the cholinergic system.
Hypotheses:
It is expected that after approximately 28 days of estradiol treatment cognitive performance will be enhanced in comparison to baseline. It is also hypothesised that estradiol will protect against the cognitive deficits associated with cholinergic muscarinic receptor blockade (i.e. after administration of scopolamine).
Design:
This is a double blind placebo controlled 31-day study in which participants will be randomly allocated to either receive 100 g transdermal estradiol or a placebo. An extensive cognitive battery will be administered at baseline and again after 28 days of treatment. The cognitive tests will examine attention and psychomotor speed, object and spatial working memory, immediate and delayed visual and verbal memory, recognition, mental alertness, information processing and cognitive flexibility. Whilst still on the estrogen/placebo treatment participants will be given 0.4mg of scopolamine/placebo via injection and then asked to perform the cognitive test battery the same day. After a 2-day washout period the same procedure will be carried out with the alternate treatment (scopolamine/placebo), after which estrogen/placebo treatment will cease.
Participants:
We are seeking women who are in the postmenopausal stage of life and have never before received hormone replacement therapy and who are non-smokers. Prior to inclusion into the study all participants will undergo a physical and psychiatric examination by a medical doctor.
Exclusion criteria:
- history of psychiatric illness
- epilepsy or any serious medical condition
- menopausal or pregnant women and lactating mothers
- diabetes or a history of diabetes
- malignancies or history of familial breast cancer or fibrocystic mastopathy
- abuse of alcohol
- hyperlipidemia
- cardiovascular or endocrinologic disease or peptic ulcers
Investigators:
Professor Jayashri Kulkarni
Jacynth Liew
Kathryn Garland
Background:
Oral contraceptives (OCs) are used by 1 in 4 women between the ages of 18 and 49, being the primary method of choice of 40% of all contraceptive users (National Health Survey 1995). In Australia, about 1 in 4 women will suffer from depression during their lifetime (WHO). Depression is the most common reason given for discontinuation of OC use (Goldzieher J., 1994).
Objective:
This recently completed pilot study aimed to investigate the relationship between usage of combined oestrogen and progesterone contraceptive pills (COCs) and depression, by quantifying the level of depression in each subject using an amalgam of depression rating scales.
Design:
The study involved sixty subjects in two groups, of current COC users and non-COC users. Subjects underwent two interviews at different points in their menstrual cycle, where they were assigned an amalgam score from a number of different depression rating scales. These included the Beck Depression Inventory, the Hamilton Depression Scale, the Montgomery-Asberg Depression Rating Scale, the CORE Assessment of Psychomotor Change, and the DSM-IV Global Assessment of Functioning Scale.
By analysing and comparing scores between the two groups, we then examined whether COC users are more likely to be depressed or suffer more severe depression than non-users.
Participants:
This study recruited women of reproductive age, including both non-users and users of COCs. Women were required to meet certain inclusion criteria before starting the study. Women enrolled were of a) reproductive age, b) had no major adverse events in the recent 3 months, c) not pregnant or lactating, d) not currently taking antidepressant medication.
Results:
Women using combined oral contraceptives reported significantly more depressive symptoms on all self-report measures (MADRS: F(1, 56)=11.75, p<0.01; HAMD: F(1,56)=11.81, p<0.01; BDI-II: F(1,56)=6.89, p<0.05) and a lower level of functioning (F(1,56)=13.10, p<0.01) than women not using combined oral contraceptives. Depression scores fell into the mild depression range for the combined oral contraceptive users but the normal range for the non-users.
Conclusions:
Considering the extent of oral contraceptive use within the female population, its impact on mood is an important public health issue that requires in-depth investigation. Thus, the findings of this pilot study, while limited, should be taken into consideration by medical practitioners when treating women on the pill who report symptoms of lowered mood. Further investigation of the association between oral contraceptives and depression is warranted. We hope to soon undertake a larger study at APRC looking at this important issue. Women who are potentially interested in taking part are encouraged to register their interest with the centre.
Student Researcher:
Ms Angela Papadimitriou
Supervisors:
Professor Jayashri Kulkarni (APRC)
Professor Kim T. Ng (Monash University)
Dr Carol Hulbert (SPECTRUM)
Background:
Whilst Borderline Personality Disorder (BPD) is receiving widespread clinical attention, the role and phenomenology of psychotic symptoms in the syndrome remain unclear. The controversy revolves around the question of whether narrowly defined, or true psychotic symptoms, are part of the fundamental psychopathology of BPD, or manifestations of co-occurring Axis-I or Axis-II disorders. The debate is further fuelled by the proposition that psychotic symptoms in BPD are different from ordinary psychoses in that they may have little effect on the patient's functioning, be atypical and possibly factitious.
Despite studies arguing that true psychotic symptoms in BPD are rare and attributable to concomitant Axis I or Axis II disorders, contrary findings have suggested that such symptoms may occur in the presence or absence of a concurrent disorder and be common among patients with BPD.
Within the range of true psychotic symptoms, auditory hallucinations have been reported as more prevalent in BPD than delusions. The SPECTRUM Personality Disorder Service for Victoria reports that 49% of their clients, all with a primary diagnosis of Borderline Personality Disorder, experience auditory hallucinations from 10% to 100% of the time. Notwithstanding the evidence of auditory hallucinations in individuals with BPD, the phenomenology of these symptoms in the disorder has not yet been sufficiently investigated. The limited empirical findings on true psychotic symptoms in BPD have relied exclusively on generic diagnostic instruments that contain only few items assessing auditory hallucinations, and are thus inadequate to perform a detailed assessment of this symptom.
Given the implications of the psychosis debate to the diagnosis of BPD, the comprehensive examination of auditory hallucinations might not only be of diagnostic value but also of clinical importance. Additionally, the assessment of individuals' attitudes and coping strategies associated with auditory hallucinations will also improve the understanding of this psychotic symptom in the context of the individual's mental disorder, current life situation and quality of life. This will also provide an adjunct to cognitive therapy, in which an attempt is made to change the beliefs about the hallucinations and ultimately assist the individual cope with hearing voices.
Aims:
The aim of this study is to investigate the phenomenology, attitudes and beliefs associated with auditory hallucinations in BPD, using a questionnaire (clinical structured interview and self-report questionnaire) designed to assess this psychotic symptom. Specifically the goals are to examine:
- the phenomenological characteristics of auditory hallucinations in BPD
- the beliefs, attitudes and coping strategies associated with auditory hallucinations in BPD
- whether specific aspects of auditory hallucinations differentiate individuals with BPD and Schizophrenia
- whether the auditory hallucinations in BPD are factitious or not
Methodology
Participants:
The study comprises two groups:
- Target Population: Women aged 18 years or over, who have experienced auditory hallucinations, with a current diagnosis of BPD as defined in DSM-IV and diagnosed by the SCID-II.
- Comparison Group: Women aged 18 years or over, who have experienced auditory hallucinations, with a current diagnosis of Schizophrenia as defined in DSM-IV and diagnosed by the SCID-I.
Participants are drawn from the Alfred psychiatry services including the inpatient unit and community services as well as from the Eastern and Southern Health Community Mental Health Services.
Procedure:
- Session 1 - Diagnosis: SCID-I and SCID-II
- Session 2 - Assessment of auditory hallucinations: Auditory Hallucinations Questionnaire (AHQ). The AHQ (developed by the student researcher) comprises a semi-structured interview of phenomenological variables, as well as a self-report questionnaire on attitudinal variables and coping strategies regarding auditory hallucinations.
- Data Review: Assessment of feigned hallucinations.
Current Status:
The project is now at data analysis stage.
The National Register for Antipsychotic Medications in Pregnancy (NRAMP)
Investigators:
Prof Jayashri Kulkarni
Ms Kay McCauley
A/Prof Glenice Ives
Mr Stephen Elsom
Prof John McGrath
A/Prof P Fitzgerald
Mr Anthony de Castella
Background:
The purpose of this project is to establish a National register of women who are treated with antipsychotic medication during pregnancy. This will be a prospective study which will gather data which will enable the correlation of medication use with a variety of outcomes for both the mother and baby. This information will be recorded in a database and will establish the risk of antipsychotic medication use during the antenatal period.
Second generation antipsychotic drugs (SGAs), also referred to as atypical antipsychotics are recommended as first and second line treatments for schizophrenia and other psychotic disorders. However, none of this class of medications has been approved for use in pregnancy.
This project will use a range of standardised assessment tools (eg. the PANSS, AIMS) to measure outcomes for both mother and baby. All women who are taking antipsychotic medications during pregnancy will be eligible to participate. Recruitment strategies will include presentations and mail out of information regarding the research to healthcare professionals around Australia; as well as advertising via the media. The information is to be collected by telephone interview during the pregnancy and the first year after birth.. Medical details will also be obtained from the treating medical practitioners.
The project has been approved by the following human research ethics committees (HRECs) from around Australia: Monash University, The Alfred hospital, Peninsula Health, Southern Health, Latrobe Regional Hospital in Victoria, University of Tasmania, Queensland Health Cairns District Hospital, King Edward Memorial Hospital and Joondalup (Mayne Health) in Western Australia. Ethics approval is pending for many other sites including Royal Darwin Hospital, Queen Elizabeth/Lyell McQuen Hospital in South Australia .
The establishment of this national register is an important strategy in improving the management of serious mental illness such as schizophrenia and other psychotic disorders, in women who are pregnant.
Objectives:
- To establish a National Register of pregnant women taking antipsychotic medication.
- To gather evidence regarding the outcomes of antipsychotic use for pregnant women and their babies
- To develop clinical practice guidelines for the use of antipsychotics during pregnancy
Method:
Project design: Setting up a National Register. This national register will explore the safety of antipsychotic medication use in pregnant women with psychosis.
Modelled on the “Anticonvulsants in pregnancy register” (Vajda et al, St Vincent’s Hospital – personal communication, 2003).
The register will detail the following information required. Each participant will be given a code number. Demographic and psychosocial data will be gathered including date of first interview, date of birth, ethnicity, occupation, address, family history of illness (physical & psychiatric), obstetric details - expected delivery date, (ultrasound gestation assessment in weeks, any abnormalities and comments), any other obstetric/gynaecological tests such as CVS/amniotic sampling, previous pregnancy details. Information regarding the woman’s medical history such as her medication history – past and present, past and current schizophrenia history (and other psychiatric disorders), smoking and alcohol intake details, other illicit drug details, coffee/tea consumption details. The names and contact details of her treating medical officers along with access to her medical records will also be attained.
Psychopathology assessments with be conducted with the the Positive and Negative Syndrome Scale (PANSS) and the Edinburgh Postnatal Depression Scale (EDPS). Entry diagnosis is by checklist chart diagnosis of psychosis plus treatment with antipsychotic medications.
Criteria for Inclusion/exclusion of participants. This study includes women with a history of severe mental illness with psychotic features who are pregnant. These disorders include DSM IV schizophrenia and other associated disorders such as bipolar affective disorder with psychosis and schizoaffective disorder, first presentation psychosis, previous puerperal psychosis, borderline personality disorders with auditory hallucinations, major depression with psychotic symptoms.
These women may be treated prior to and during pregnancy with an antipsychotic medication, but this is not an inclusion/exclusion criteria for the register as the treating medical officer may alter medication treatment at various times during the pre-pregnancy, antenatal and postpartum period. For this reason also, it is important to enrol women who may be on the older and newer antipsychotics, to capture the wider clinical picture of the use of medications.
Ethics approvals:
This National register has ethical approval from Human Research and Ethics committees from around Australia, with many more pending. Approval has been attained for the involvement of women attending clinical sites from both public and private health care sectors. The details of approvals to date are as follows:
Victoria - Monash University, The Alfred, Southern Health, Peninsula Health, LaTrobe Regional, Eastern Health
South Australia - Queen Elizabeth, Lyell McQuen
Tasmania - University of Tasmania, Royal Hobart Hospital
Western Australia - Joondalup Hospital, Mayne Health, St John of God Hospitals, King Edward Memorial Hospital
Queensland - Queensland Health, Cairns District Hospital
Ethical approval for many other sites around Australia are currently being processed.
Ethical approval has also included meeting the criteria for involvement of women from the indigenous communities.
Method Of Participation:
- The patient’s clinician (General Practitioner, Midwife, Psychiatrist, Case Manager, Obstetrician and other) refers the patient to Researcher, Kay McCauley (03 9276 6564).
- Information packages and consent forms are given to patient who forwards these to the researchers.
- Researcher contacts patient.
- Patient's details are recorded and then phone/face-to-face interviews commence. Details from her medical file are required.
- Follow up of patient by researcher for duration of pregnancy and for the first year of baby’s life.
Recruitment Strategies:
- Targeting clinicians to obtain referrals of women who are on antipsychotic mediation and pregnant.
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