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Clinical Trials/NCT00893256
NCT00893256
Completed
Phase 4

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

National Institute of Mental Health and Neuro Sciences, India1 site in 1 country48 target enrollmentDecember 2004

Overview

Phase
Phase 4
Intervention
risperidone
Conditions
Schizophrenia
Sponsor
National Institute of Mental Health and Neuro Sciences, India
Enrollment
48
Locations
1
Primary Endpoint
Change in PANSS negative symptom score
Status
Completed
Last Updated
17 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 2004
End Date
September 2007
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Institute of Mental Health and Neuro Sciences, India

Eligibility Criteria

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

Arms & Interventions

Risperidone and citalopram

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)

Intervention: risperidone

Risperidone and citalopram

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)

Intervention: Citalopram

Risperidone and placebo

24 patients were randomized to receive add-on placebo in a double-blind fashion to open-label treatment with risperidone (4-8 mg/day)

Intervention: risperidone

Risperidone and placebo

24 patients were randomized to receive add-on placebo in a double-blind fashion to open-label treatment with risperidone (4-8 mg/day)

Intervention: Placebo

Outcomes

Primary Outcomes

Change in PANSS negative symptom score

Time Frame: 12 weeks

Secondary Outcomes

  • Change in PANSS total score(12 weeks)

Study Sites (1)

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