Efficacy and distinctive effects of atypical antipsychotics on cognitive symptoms in dual diagnosis – A phase IIIb, randomized, open-labelled study to evaluate the cognitive effects of quetiapine XR and olanzapine in patients with schizophrenia and substance abuse

• Conditions: Patients with both schizophrenia and substance abuse disorder

• Registration Number: EUCTR2007-001520-12-PT
• Lead Sponsor: nidade de Investigação em Saúde Mental e Psiquiatria do Centro Hospitalar Conde de Ferreira

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

For inclusion in the study subjects must fulfil all of the following criteria:
1. Provision of written informed consent
2. A diagnosis of dual diagnosis (schizophrenia and substance abuse disorder) by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
3. Males aged 18 through 65 years
4. Able to understand and comply with the requirements of the study
5. In or outpatients abstinent of non prescribed drugs, like heroine, cocaine, or cannabis, for at least 20 days checked by urinalysis, not taking quetiapine or olanzapine in the last 6 months.
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

Any of the following is regarded as a criterion for exclusion from the study:
1. Any DSM-IV Axis I disorder not defined in the inclusion criteria
2. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
3. Known intolerance or lack of response to quetiapine fumarate or to olanzapine, 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 enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, 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. diabetes, congestive heart failure [mandatory since doses are >400mg] 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 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 enrollment 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 randomization. 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) less or equal to 1.5 x 10^9 per liter.
14. Abnormal liver function (hepatic enzymes > 3 x the upper normal limit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified