A comparison study of quetiapine medication and psychological therapy versus placebo tablets and psychological therapy in patients who are deemed at risk of developing a psychotic disorder.
- Conditions
- Prodromal PsychosisMental Health - Psychosis and personality disordersMental Health - Schizophrenia
- Registration Number
- ACTRN12610000244000
- Lead Sponsor
- Orygen Youth Health Research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 163
For inclusion in the study patients must fulfil all of the following criteria:
1. Provision of written informed consent
Where participants are of legal childhood age, consent will also be obtained from one of the participant’s parents. Both the parent and participant will be required to sign the consent form in such a case. It will be the investigator’s responsibility to determine whether a participant of legal childhood age has the capacity to consent to the study
2.Females and males aged 15 to 40 years depending on site
3.Able to understand and comply with the requirements of the study
4.Be a member of the one of the following UHR groups:
Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a trait risk factor (schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in mental state and/or functioning or sustained low functioning during the past year.
Attenuated Psychotic Symptoms (APS) Group: Individuals with subthreshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year and be associated with a significant reduction in or sustained low functioning.
Brief Limited Intermittent Psychotic Symptoms Group (BLIPS): Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year and be associated with a significant reduction in or sustained low functioning.
Any of the following is regarded as a criterion for exclusion from the study:
1. Pregnancy or lactation
2. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others, as operationalised with a current Comprehensive Assessment of At Risk Mental States (CAARMS) aggression/dangerous behaviour severity score of 5-6 or current CAARMS suicidality/self-harm score of 5-6
3.Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
4.Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir.
5.Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampicin, St. John’s Wort, and glucocorticoids.
6.Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation.
7.Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
8. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator.
9. Involvement in the planning and conduct of the study
10. Previous enrolment or randomisation of treatment in the present study
11.Participation in another drug trial within 4 weeks prior to enrolment into this study or longer in accordance with local requirements
12. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
* Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%.
* Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
* Not under physician care for DM
* Physician responsible for patient’s DM care has not indicated that patient’s DM is controlled.
* Physician responsible for patient’s DM care has not approved patient’s participation in the study
* Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks.
* Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks
Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
13. An absolute neutrophil count (ANC) of 1.5 x 109 per liter.
14 Past history of a treated or untreated psychotic or manic episode of one week duration or longer, as rated using the CAARMS
15. Organic brain disease, e.g. epilepsy, inflammatory brain diseases
16. (Liver Function Tests) LFTs and Kreatinine and electrolytes (U+Es) outside the normal range
17. Current treatment with lithium, methyl phenidate or ketamine
18. Intelligence Quotient (IQ) < 70, as recorded in medical history
19. Current or past antipsychotic treatment longer than 1 week (seven days).
20. Present or past diagnosis of a schizophrenic, schizophreniform, schizoaffective, delusional, bipolar, or mood disorder with psychotic features according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) I
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the effect of quetiapine, in addition to CBCM, on the incidence of first episode psychosis in an Ultra High Risk (UHR) group.[The primary outcome variable is the rate of transition to psychotic disorder in the two treatment groups at 6 months post study entry.<br><br>This will be measured using the Comprehensive Assessment of At Risk Mental States (CAARMS). The CAARMS is a semi-structured interview-based instrument designed to assess attenuated and frank psychotic symptoms, in addition to other prodromal symptoms. The severity, frequency and duration of symptoms is measured. It is used to determine UHR status and includes operationalised criteria for full threshold psychotic disorder. The CAARMS displays good to excellent psychometric properties. The Structured Clinical Interview (SCID IV) will also be used to look at whether a patient has transitioned to psychosis.]
- Secondary Outcome Measures
Name Time Method