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

Phase 1

• Conditions: Schizophrenia; MedDRA version: 9.1Level: LLTClassification code 10039626Term: Schizophrenia

• Registration Number: EUCTR2007-000579-40-DE
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-02
• Study Completion: 2012-12-31
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Schizophrenic subjects:
-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.

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

Schizophrenic subjects:
-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 clinical trial of medicinal product
• Study Design: Not specified