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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000579-40-DE

Enrollment

Registered

2007-10-02

Start date

2007-10-10

Completion date

Unknown

Last updated

2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia

Interventions

Trade Name: Seroquel Product Name: Seroquel Pharmaceutical Form: Coated tablet CAS Number: 111974722 Other descriptive name: QUETIAPINE FUMARATE Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to detect if the activation of the ventral striatum, a key region of the pathophysiology in schizophrenia, is higher in patients treated with quetiapine compared to patients treated with haloperidol at T28. To reach this goal, a fMRI reward-motivation-paradigm, which is elaborately described in Knutson et al. (2001a/b) 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 Objective: Secondary objective is to investigate the relationship between the activation of the ventral striatum and 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 at baseline and after a 4 week treatment with either haloperidol or quetiapine. ;Primary end point(s): Primary endpoint is the difference of the BOLD contrast in the ventral striatum between the two treatment groups at T28.	—

Measure

Time frame

Main Objective: The main objective of the trial is to detect if the activation of the ventral striatum, a key region of the pathophysiology in schizophrenia, is higher in patients treated with quetiapine compared to patients treated with haloperidol at T28. To reach this goal, a fMRI reward-motivation-paradigm, which is elaborately described in Knutson et al. (2001a/b) 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 Objective: Secondary objective is to investigate the relationship between the activation of the ventral striatum and 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 at baseline and after a 4 week treatment with either haloperidol or quetiapine. ;Primary end point(s): Primary endpoint is the difference of the BOLD contrast in the ventral striatum between the two treatment groups at T28.

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026