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Selective D1 activation by addition of L-Dopa to antipsychotic treatment in patients with schizophrenia

Phase 3
Withdrawn
Conditions
psychosis
schizophrenia
10039628
Registration Number
NL-OMON36435
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

All patients will be recruited from the Psychiatry ward of the Erasmus Medical Center, Rotterdam, and diagnosed according to DSM-IV criteria by a senior psychiatrist Patients will be included if they meet the criteria for schizophrenia. Further inclusion criteria inpatients aged 18-40 years with a diagnosis of schizophrenia, stable under haloperidol or risperidone treatment (<=20 points, or >3 points on no more than three items on PANSS positive symptom scale), with significant negative symptoms (total of >20 points, or >3 points on two items on PANSS negative symptom scale) are eligible for the study.

Exclusion Criteria

pregnancy,use of psychotropic medication other than benzodiazepines serious neurological disorders. Subjects will also be excluded when they cannot understand Dutch language sufficiently to understand the purposes and implications of the experiment.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>- change in verbal learning as assessed by the Hopkins Verbal Learning Test<br /><br>Revised (HVLT-R), as compared between patients receiving L-dopa vs those<br /><br>receiving placebo<br /><br>- change in working memory as assessed by the N-back task, as compared between<br /><br>patients receiving L-dopa vs those receiving placebo<br /><br>- change in the severity of negative symptoms, as assessed by the PANSS<br /><br>negative symptoms subscale, as compared between patients receiving L-dopa vs<br /><br>those receiving placebo</p><br>
Secondary Outcome Measures
NameTimeMethod
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