Effects of atypical versus typical neuroleptics on motivation, hedonia, and social cognition in patients with schizophrenia – an fMRI study.

Phase 4

• Conditions: F20.0; Paranoid schizophrenia

• Registration Number: DRKS00004559
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2011-01-21
• Study Start: 2012-11-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Patients with schizophrenia (diagnosis according to Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV))
-Females and males age 18-60 years with schizophrenia
-Righthandedness
-German native language
-PANSS negative score = 15 points at inclusion
-Treatment with haloperidol for at least 7 days.
-Women of childbearing potential must have a negative urine human chorionic gonadotropin (HCG) test at enrolment and will be required to use a highly effective method of birth control (Pearl-Index <1) for the duration of the study to prevent pregnancy. Acceptable methods include combined oral contraceptives, implants, TDS, vaginal rings, injectables, progestin-releasing IUDs or combinations of progestin minipill and condom, copper-containing IUD and condom, diaphragm/spermicide and condom, sexual abstinence or sterilisation (including vasectomy)
-Written informed consent (AMG § 40 (1) 3b)
-Ability to understand and comply with the requirements of the study

Exclusion Criteria

-Pregnancy or lactation
-Ineffective contraception (Pearl-Index >1)
-Any DSM-IV Axis I disorder not defined in the inclusion criteria
-Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
-Contraindications, interactions, warnings, known intolerance or lack of response to quetiapine or to haloperidole, as judged by the investigator
-Treatment resistant patients (nonresponse to at least two antipsychotic agents given previously for a sufficient time and in adaequate dose)
-Use of cytochrome P450 3A4 inhibitors and inducers, in particular: carbamazepine, in the 14 days preceding enrolment
-Administration of a long-acting antipsychotics within two dosing intervals (for the depot) before randomisation
-Subjects receiving antidepressants for the treatment of negative symptoms of schizophrenia or depression (Axis I)
-Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
-Relevant abuse of opiates, amphetamine, barbiturate, cocain, cannabis, or hallucinogen within 2 weeks prior to enrolment
-Medical conditions that would affect absorption, distribution, metabolism or excretion of study treatment
-Unstable or inadequately treated medical illness (e.g. diabetes mellitus, neutropenia, leukopenia, angina pectoris, hypertension) as judged by the investigator
-Systemic disease affecting cerebral function
-Organic cerebral or neurological disease
-Involvement in the planning and conduct of the study
-Participation in another drug trial within 4 weeks prior to and during enrolment into this study
-Previous enrolment or randomisation of treatment in the present study
-Inpatient treatment by legal order (AMG §40 (1) 4)
-Contraindications to MRI-examination without contrast enhancement (metallic foreign bodies, claustrophobia, inability to lie still)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to detect if the activation of the ventral striatum, is higher in patients treated with quetiapine compared to patients treated with haloperidol at T28. To reach this goal, a reward-motivation-paradigm, which is elaborately described in Knutson et al. 2001 and Juckel et al. 2006, will be carried out before and after a 4-week treatment with quetiapine or haloperidol. Primary endpoint is the difference of the BOLD contrast in the ventral striatum between the two treatment groups at T28.

Secondary Outcome Measures

Name	Time	Method
Secondary objective is to investigate the relationship between the activation of the ventral striatum or of the dorsolateral prefrontal cortex during the reward-motivation-paradigm and negative symptoms, cognitive task performance, social cognition, insight and quality of life of the schizophrenic patients. <br>Secondary endpoints are: <br>1-the correlation of the BOLD contrast in the ventral striatum with the PANSS negative score, social cognition (MASC, IRI, RME, FPT), insight (BCIS, DIS) and quality of life (SWN-K) at T28,<br>2-the difference of the BOLD contrast in the dorsolateral prefrontal cortex between the two treatment groups at T1 and T28<br>3-the correlation of the difference of the BOLD contrast in the dorsolateral prefrontal cortex between T1 and T28 with differences of cognitive task scores (WCST, Rivermead Behav. Memory Test, Auditory Verbal Learning,), PANSS negative score (PANSS-Negativ-Score) and quality of life (SWN-K).