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

NCT ID: NCT00893256

Last Updated: 2009-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2007-09-30

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.

Conditions

Schizophrenia; Negative Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Risperidone

Intervention Type: DRUG

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

Citalopram

Intervention Type: DRUG

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

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)

Group Type: PLACEBO_COMPARATOR

risperidone

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Placebo: once daily

Interventions

Risperidone

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

Intervention Type: DRUG

risperidone

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

Intervention Type: DRUG

Citalopram

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

Intervention Type: DRUG

Placebo

Placebo: once daily

Intervention Type: DRUG

Other Intervention Names

Respidon; Respidon; Citopam

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health and Neuro Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

NIMHANS

Principal Investigators

John P John, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Mental Health and Neurosciences, Bangalore, INDIA

Locations

National Institute of Mental Health and Neurosciences (NIMHANS)

Bangalore, Karnataka, India

Countries

India

Other Identifiers

NFRPA/006/2004

Identifier Type: -

Identifier Source: org_study_id