RIS-CIT-SCH: Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia

Sponsor

National Institute of Mental Health and Neuro Sciences, India (Other)

Overall Status

Completed

CT.gov ID

NCT00893256

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Negative Symptoms	Drug: Risperidone Drug: risperidone Drug: Citalopram Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2004

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Drug: Risperidone Risperidone: tablet; oral; 4-6 mg/day; once daily; 12 weeks Other Names: Respidon Drug: Citalopram Citalopram: tablet; oral; 20 mg/day; once daily; 12 weeks Other Names: Citopam
Placebo Comparator: 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)	Drug: risperidone Risperidone: tablet; 4-8 mg/day; once daily; 12 weeks Other Names: Respidon Drug: Placebo Placebo: once daily

Arm

Intervention/Treatment

Experimental: 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)

Drug: Risperidone

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

Other Names:

Respidon

Drug: Citalopram

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

Other Names:

Citopam

Placebo Comparator: 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)

Drug: risperidone

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

Other Names:

Respidon

Drug: Placebo

Placebo: once daily

Outcome Measures

Primary Outcome Measures

Change in PANSS negative symptom score [12 weeks]

Secondary Outcome Measures

Change in PANSS total score [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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