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Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia

NCT00893256 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2009-05-05

No results posted yet for this study

Summary

Negative symptoms in schizophrenia present a challenge to the clinician owing to their poorer response to conventional treatment with antipsychotics. Negative symptoms in schizophrenia may be secondary to psychotic symptoms, depressive symptoms, drug-related side effects or lack of environmental stimulation. Alternately, they may represent core features of the illness, characterized as primary deficit symptoms. Previous studies have suggested that atypical antipsychotics may be beneficial in improving deficit symptoms of schizophrenia. This study aimed at characterizing the nature of improvement of negative symptoms in the early phase (12 weeks) of treatment with the atypical antipsychotic, risperidone. In order to account for factors contributing to improvement in secondary negative symptoms, ratings were carried out of change in positive symptoms, depressive symptoms and drug-related side effects. Further, add-on citalopram or placebo were administered in a double-blind design to study the effect of selective serotonin reuptake inhibitor (SSRI) augmentation of risperidone on negative symptoms. The investigators hypothesized that the improvement in negative symptoms during the initial phase (12 weeks) of treatment with risperidone will be largely accounted for by improvement in secondary negative symptoms, rather than of the primary deficit symptoms.

Conditions

Interventions

DRUG

Risperidone

Risperidone: tablet; oral; 4-6 mg/day; once daily; 12 weeks

DRUG

risperidone

Risperidone: tablet; 4-8 mg/day; once daily; 12 weeks

DRUG

Citalopram

Citalopram: tablet; oral; 20 mg/day; once daily; 12 weeks

DRUG

Placebo

Placebo: once daily

Sponsors & Collaborators

  • National Institute of Mental Health and Neuro Sciences, India

    lead OTHER

Principal Investigators

  • John P John, M.D. · National Institute of Mental Health and Neurosciences, Bangalore, INDIA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • India

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00893256 on ClinicalTrials.gov