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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Double-Blind Randomized Comparison Study of Improvement in Negative Symptoms With Risperidone vs Risperidone +Citalopram Combination Therapy in Schizophrenia--a Clinical Study

Conditions
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Schizophrenia, Negative Symptoms

Intervention / Treatment
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* Drug: Risperidone
* Drug: risperidone
* Drug: Citalopram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients fulfilling DSMIV Criteria for Schizophrenia The patient should be drug naïve or drug free for one month (oral antipsychotic) or three months of parental antipsychotic Duration from onset < 5 years Informed consent Exclusion Criteria: Patient with any other current Axis I or Axis II comorbid disorders Comorbid substance abuse or dependence except nicotine or caffeine Presence of significant medical disorder such as epilepsy, uncontrolled hypertension and diabetes mellitus, thyroid disorder Patient who has not responded to adequate course of risperidone (with reference to dose and duration) Treatment-resistant schizophrenia defined as non-response to three different antipsychotics belonging to at least two different classes, one of which is an atypical agent and one of which is a depot neuroleptic Patient who has received ECT in past 3 months

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Risperidone and citalopram<br>24 patients were randomized to receive add-on citalopram (20 mg/day) in a double-blind fashion to open-label risperidone (4-8 mg/day) | Drug: Risperidone<br>* Risperidone: tablet; oral; 4-6 mg/day; once daily; 12 weeks<br>* Other names: Respidon;Drug: Citalopram<br>* Citalopram: tablet; oral; 20 mg/day; once daily; 12 weeks<br>* Other names: Citopam;|
| Placebo Comparator: Risperidone and placebo<br>24 patients were randomized to receive add-on placebo in a double-blind fashion to open-label treatment with risperidone (4-8 mg/day) | Drug: risperidone<br>* Risperidone: tablet; 4-8 mg/day; once daily; 12 weeks<br>* Other names: Respidon;Drug: Placebo<br>* Placebo: once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PANSS negative symptom score |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PANSS total score |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, risperidone, citalopram, secondary negative symptoms