ESTAR - A FOLLOW-UP REGISTRY FOR PEOPLE TAKING RISPERDAL CONSTA
Investigators
Professor Jayashri Kulkarni
Dr Yitzchak Hollander
Dr Sally Wilkins
Dr Kerrie Chappell
Background
A non-interventional, observational web and/or paper based registry designed to assess demographic treatment and outcomes data in patients receiving treatment with Risperdal Consta.
Information will be collected on treatment at the following time points enrolment and at 3, 6, 9, 12, 15, 18, 21 and 24 months. At enrolment information on your treatment over the previous 12 months will be collected. This data will be processed for the purpose of the registry.
Hypotheses & Aims
The study proposes a multi-centre, retrospective and prospective drug utilisation review, determining drug usage patterns and outcomes associated with the use of Risperdal Consta, in clinical practice. It is believed that through such a study, information can be beneficial for decision-makers both at the health care provider and at the payer's level, since it assesses treatment patterns and outcomes in a real life situation and under real life conditions.
The purpose of this project is to:
- Assess medication usage patterns
- Document how effective the medication is
- Document the long-term treatment outcomes of Risperdal Consta in an everyday setting.
- Collect health information from the previous twelve months, which will allow the evaluation of health outcomes resulting from treatment with Risperidone Long-Acting Injection compared to previous treatments.
- Evaluate reasons for a person being prescribed Risperidone Long-Acting Injection.
Current status
Recruitment for this study has now ceased. There are currently 68 participants actively involved. Retrospective data has been obtained for all active participants, and mandatory 24-month follow-ups are underway. At present, 1 participant has completed 24-months of follow up, and up to 12-months of follow-up data has been collected for over half of the participants.
AN OBSERVATIONAL ASSESSMENT OF QUALITY OF LIFE, FUNCTIONING AND ADHERENCE IN PATIENTS TAKING RISPERDAL CONSTA
Investigators
Professor Jayashri Kulkarni
Associate Professor Paul Fitzgerald
Mr Anthony de Castella
Background
The study is an add-on study to the eSTAR project currently running. Previous experience has shown that some patients have difficulty taking medications each day, and that receiving injecetions every two weeks is a more suitable treatment. Risperdal in the injection form is a relatively new medication and while studies so far show it is safe and effective, this project is designed to establish the benefits and changes of the drug in more detail.
Information will be collected from participants at a baseline visit and four further interviews at 6, 12, 18 and 24 months after baseline. At these interviews, participants will be asked a series of questions which relate to symptoms of illness, medication, drug and alcohol use, medication side effects, suicidal and violent thoughts or actions, and questions about 'quality of life'.
Aims & Hypotheses
The aims of the study are to assess changes in the Psychopathology, Quality of Life and Occupational Functioning of participants taking Risperdal Consta over a two year period. More specifically, the study will:
- Assess the level of treatment adherence of participants treated with Risperdal Consta over a two-year period.
- Assess the safety and tolerability of Risperdal Consta over a two year period.
- Measure the levels of violence, suicidality, and drug & alcohol use in participants taking Risperdal Consta over a two-year period.
- Explore people's subjective experience of treatment with Risperdal Consta
- Assess subjective quality of life among study participants.
Current status
At present retrospective data has been collected for 27 consented participants, and baseline interviews have been conducted. Recruitment for the study is currently ongoing.
A COMPARISON STUDY OF FLEXIBLY DOSED PALIPERIDONE PALMITATE AND RISPERDAL CONSTA IN SUBJECTS WITH SCHIZOPHRENIA
Investigators
Professor Jayashri Kulkarni
Associate Professor Paul Fitzgerald
Dr Ben Goodfellow
Mr Anthony de Castella
Dr Yitzchak Hollander
Dr Sally Wilkins
Background
This is a randomised, double blind, active-controlled, parallel-group, multi-centre comparative study in men and women aged 18 years and older who have schizophrenia. The study will compare Paliperidone Palmitate with Risperdal Consta.
Paliperidone palmitate is the active metabolite of Risperidone, having selective monoaminergic antagonistic activity on D2 and 5HT2A receptors. It is being developed as a long acting intramuscular injectable aqueous-suspension formulation for the treatment of schizophrenia.
The study comprises a screening period of < 7 days followed by a 53-week treatment period. In the treatment period, subjects will be randomly assigned to either receive an intramuscular injection of Paliperidone palmitate every 4 weeks or Risperdal Consta® every 2 weeks.
Hypotheses & Aims
The primary objective is to demonstrate that Paliperidone Palmitate and RISPERDAL CONSTA have comparable efficacy.
Throughout the study following secondary assessments will be made with regard to the use of Paliperdone Palmitate compared to RISPERDAL CONSTA:
- Assessment of global improvement in severity of illness
- Assessment of the benefits to personal and social functioning
- Evaluation of symptomatic remission
- Exploration of the pharmacokinetics of Paliperidone Palmitate.
Current status
Recruitment for this study has now ceased. Seven participants have been screened, and six have consented into the study. Three participants remain in the study.
Onyx Study- A Study Assessing The Efficacy And Safety Of Seroquel Sustained Release In Combination With An Anti-Depressant, In The Treatment Of Patients With Major Depressive Disorder Who Have History Of Inadequate Response To Anti-Depressant Treatment
Investigators
Professor Jayashri Kulkarni
Associate Professor Paul Fitzgerald
Dr Gregory Been
Mr Anthony de Castella
Background
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR™) in Combination with an Antidepressant in the Treatment of Patients with Major Depressive Disorder with Inadequate Response to an Antidepressant Treatment.
SEROQUEL Sustained Release is a newer formulation of a current drug called Seroquel. At present, Seroquel is currently approved for use in Australia to treat schizophrenia and mania associated with Bipolar 1 Disorder, it is not approved for the treatment of Major Depressive Disorder. The study drug - SEROQUEL SR - is not currently approved for therapeutic use in Australia. Previous research using SEROQUEL has shown improvements in patients with Major Depressive Disorder.
The study involves a washout period of up to 14 days, followed by randomization into a treatment/placebo groups. In the 6-week treatment period participants will attend weekly visits for the first two weeks, and fortnightly visits thereafter. During each visit data will be collected via completion of several rating scales/questionnaires, blood/urine samples and physical examinations (including ECG).
Aims & Hypotheses
The primary objective of the project is to see if Seroquel SR in combination with the participant's current anti-depressant is effective in treating their Major Depressive Disorder.
Secondary objectives include evaluation of improvements in quality of life, anxiety and somatic symptoms, sleep quality, occurrence of suicidal ideation, satisfaction with medication, safety and tolerability of Seroquel SR; and effects on plasma levels of antidepressant treatment.
Current status
Ethics approval for this study has been obtained and telephone interviews have been performed for approximately 50 individuals. At present, five patients are enrolled and two have completed their treatment. Recruitment is ongoing.
MULTI-COMPONENT RISK FACTOR INTERVENTION FOR PEOPLE WITH A SEVERE MENTAL ILLNESS: A FEASIBILITY STUDY
Investigators
Professor David Castle
Dr Amanda Baker
Professor Robyn Richmond
Professor Jayashri Kulkarni
Ms Toni Ryan
Ms Margarat Forgarty
Background
The proposed study will assess the feasibility of a multi-component behavioural intervention focusing on smoking cessation/diet/physical activity, in order to enhance healthy living among young people with psychotic disorders.
The study will involve cognitive behavioural therapy with the adjunct of nicotine replacement therapy; in addition to an intensive three-month physical training program with subsequent review sessions every three months over a twelve-month period. Participants will also be advised as to reduction of current calorie intake.
Aims & Hypotheses
The primary aim of the study is to assess the feasibility of conducting a multi-component risk factor intervention to promote smoking cessation and change in body mass index among people with psychosis.
Secondary aims are to determine the effect of the multi-component risk factor intervention on the control of serum lipids and blood sugar levels in people with psychosis, and to establish whether reduction in smoking cessation and obesity is correlated with body image, reduced depression levels and quality and enjoyment of life.
Current status
Ethics approval has been obtained and recruitment will commence shortly.
A STUDY ASSESSING THE EFFICACY AND SAFETY OF AGOMELATINE IN COMBINATION WITH A MOOD-STABILIZER, IN THE TREATMENT OF PATIENTS WITH BIPOLAR 1 DISORDER
Investigators
Professor Jayashri Kulkarni
Associate Professor Paul Fitzgerald
Dr Gregory Been
Mr Anthony de Castella
Background
This is an 8-week randomised, double-blind, controlled, parallel groups study which is followed by a double-blind extension treatment period up to one year.
Agomelatine is a melatonin agonist and a serotonin antagonist. The antidepressant efficacy of this particular drug has been confirmed in subgroups of patients with severe depression. Besides its antidepressant activity, agomelatine has beneficial effects on sleep disorders, which is a major feature of bipolar disorder both in depressive and manic phases.
This study involves a wash-out period of up to ten days, followed by randomization into either the treatment (25mg with potential adjustment to 50mg at week two) or placebo group. Participants will be required to attend fortnightly visits for eight weeks. Study visits will involve completing questionnaires/interviews on sleep, quality of life, emotional state and anxiety levels. Participants will also be questioned regarding their experience of any adverse events. Routine physical examinations will also be performed, in addition to several blood tests and electrocardiograms (ECG). Participants will have the option of continuing in the double-blind extension period up to one year, whereby they will attend seven study visits in total (monthly intervals until month six and two-monthly intervals thereafter).
Aim & Hypotheses
The primary objective of this study is to evaluate the antidepressant efficacy of agomelatine versus placebo, in addition to the participant's current mood stabilizer, in patients with Bipolar 1 Disorder with a current depressive episode.
Secondary objectives include assessment of the safety of agomelatine in conjunction with mood stabilizer treatment. An additional aim is to also obtain preliminary data on agomelatine maintenance of efficacy, in the optional extension period.
Current status
Recruitment for this study has commenced, and approximately twenty people have been screened.
PLATINUM STUDY - IS SEROQUEL SUSTAINED RELEASE AN EFFECTIVE TREATMENT FOR GENERALISED ANXIETY DISORDER?
Investigators
Professor Jayashri Kulkarni
Associate Professor Paul Fitzgerald
Dr Gregory Been
Mr Anthony de Castella
Background
Seroquel SR is currently prescribed in the treatment of bipolar depression and some psychotic illnesses, notably schizophrenia and schizoaffective disorder. Research has indicated that Seroquel SR should also be an effective long-term treatment for anxiety. In patients with bipolar depression, Seroquel SR has been shown to reduce anxiety symptoms in comparison to placebo.
Aims & Hypotheses
The APRC is currently conducting a study to assess the effectiveness of Seroquel SR as a treatment for Generalised Anxiety Disorder. The study is a 70-week, double-blind trial, whereby suitable participants are randomly assigned to take either Seroquel SR or a placebo. During the study, ratings of physical and mental functioning are made, including ECGs and eye examinations. The provision of the study medication to suitable clients after their involvement in the study ends is a possibility.
Current status
Ethics approval has been obtained. Recruitment has commenced and two people are currently enrolled.
Investigators:
Dr Paul Fitzgerald
Prof Jayashri Kulkarni
Study Staff:
Ms Sacha Filia
Amoxapine has been used predominantly as an antidepressant medication in the past. More recently, Amoxapine has been successfully applied in the treatment of psychotic features in both depression and schizophrenia. Research has indicated that there are several reasons why Amoxapine should demonstrate atypical antipsychotic properties. The results of a recent international study using Amoxapine in schizophrenia have indicated clinical efficacy, and freedom from extrapyramidal side-effects and weight gain.
The APRC is currently conducting a study to investigate the use of Amoxapine as treatment for psychotic symptoms in people experiencing schizophrenia or schizophreniform disorder. The study is an 8 week, double-blind trial, whereby suitable participants are randomly assigned to take either Amoxapine or Olanzapine. During the study, ratings of symptoms are made, and plasma prolactin, weight and possible extrapyramidal side-effects are monitored. The provision of the study medication to suitable clients beyond the 8 weeks is a possibility. Recruitment for this project is still ongoing.
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