| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Patients with both schizophrenia and substance abuse disorder |
|
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To evaluate efficacy of quetiapine XR and olanzapine on cognitive symptoms in dual diagnosis patients. |
|
| E.2.2 | Secondary objectives of the trial |
To evaluate differential effects of quetiapine XR and olanzapine on cognitive symptoms.
To evaluate differential effects of quetiapine XR and olanzapine on quality of life.
To evaluate safety of quetiapine XR and olanzapine in dual diagnosed patients (schizophrenia and substance abuse)
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. |
|
| E.4 | Principal 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. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary variable will be the cognitive patterns which will be evaluated by determining cognitive domains performances using the ACECF battery (Conde Ferreira Standardized Cognitive Evaluation). This battery includes the following psychometric instruments:
Wechsler Adult Intelligence Scale – III – Vocabulary
Wechsler Adult Intelligence Scale – III - Similarities
Wechsler Adult Intelligence Scale – III - Picture Competition
Clock Draw Test - Total Score
Rey Complex Figure - Copy
Rey Complex Figure - Recall
MMSE – Mini Mental State Examination
STROOP Color and Word Test - Word Reading
STROOP Color and Word Test - Color Naming
STROOP Color and Word Test - Color-Word reading
STROOP Color and Word Test - Interference
Wisconsin Card Sorting Test - Total number of errors
Wisconsin Card Sorting Test - Perseverative responses
Wisconsin Card Sorting Test - Perseverative Errors
Wisconsin Card Sorting Test - Non-perseverative errors
Wisconsin Card Sorting Test - Number of categories completed
Wisconsin Card Sorting Test - Failure to maintain set
Wechsler Memory Scale-III - Logical memory I & II
Wechsler Memory Scale-III - Faces Recognition I & II
Wechsler Memory Scale-III - Verbal Paired Associates I & II
Wechsler Memory Scale-III - Family Pictures I & II
Wechsler Memory Scale-III - Auditory Recognition Delayed
Wechsler Memory Scale-III - Visual Memory Delayed
Wechsler Memory Scale-III - Letter-Number Sequencing
Wechsler Memory Scale-III - Working Memory
Wechsler Memory Scale-III - Letter-Number Sequencing
Wechsler Memory Scale-III - Spatial Span
Wechsler Memory Scale-III - Working Memory
Hopkins Verbal Learning Test - Total and Delayed Recall
Hopkins Verbal Learning Test - Third trail learning
Hopkins Verbal Learning Test - Recognition Discrimination Index
Trail Making Test - A & B
Continuous Performance Test II - Omissions & Commissions
Continuous Performance Test II - Hit Reaction Time
Finger Tapper Test - Right and Left
BSI – Brief Symptom Inventory (non- cognitive assessment) |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Subjects will complete their participation in this trial 6 months after the screening/randomization visit, after completing 8 visits according to protocol. However, any subject may be discontinued from study treatment and assessments at any time. Specific reasons for discontinuing a subject from this study are described in section 3.3.3 of the protocol. In the same section it is also possible to find the procedures for subject discontinuation.
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
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