CONSTATRERisperdal Consta Trial of Relapse Prevention and Effectiveness - CONSTATRE

Conditions: SCHIZOPHRENIA, SCHIZOAFFECTIVE DISORDER

Registration Number: EUCTR2004-000870-29-SE

Lead Sponsor: Janssen-Cilag Medical Affairs EMEA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 691

Inclusion Criteria

- Male or female.
- Age at least 18 years.
- Diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)
- Patients currently treated with oral risperidone, olanzapine or conventional neuroleptic monotherapy at doses not exceeding 6 mg for risperdal, 20 mg for olanzapine or a conversion dose of 10 mg haloperidol for oral conventional agents
- Female patients must be surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intra-uterine device, double-barrier method, contraceptive patch, male partner sterilisation or abstinence) before entry and throughout the study; and have a negative urine pregnancy test at baseline, before study entry.
- Patients need to be stable (judged clinically stable by the investigator and on a stable dose of medication for 4 weeks or longer) but not optimally treated (non satisfactory treatment regarding symptoms or side effects) and living in the same residence for 30 days
- Patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Patient's relative or caregiver has signed an informed consent indicating that he/she is willing to participate in the trial to provide information in case the patient experiences a relapse during the evaluation period. If this relative or caregiver consent cannot be obtained, the patient can still participate in the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- DSM-IV axis I diagnosis other than schizophrenia or schizoaffective disorder.
- Patients treated with other antipsychotics than oral risperidone, olanzapine or conventional oral neuroleptics.
- Patients who are known non-responders to previous treatment with at least 2 antipsychotics.
- Patients who are known non-responders to quetiapine, aripiprazole or oral risperidone proven by adequate drug plasma levels (non-responders due to non-compliance are not excluded).
- Patients treated with mood stabilisers or antidepressants who are not on a stable dose for at least 3 months prior to trial entry.
- Evidence of alcohol or drug abuse or dependence (except for nicotine and caffeine dependence) according to DSM-IV criteria diagnosed in the last month prior to entry.
- Pregnant or breast-feeding females.
- Patients having received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
- History of severe drug allergy, drug hypersensitivity or neuroleptic malignant syndrome.
- Clinically significant laboratory abnormalities.
- Known clinically significant ECG abnormality.
- Patients with mental retardation.
- Patients with a known hypersensitivity to risperidone, quetiapine or aripiprazole.
- Patients with acute risk of suicide in the investigator opinion at study entry or a history of suicidal attempt(s).