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

Schizophrenia Clinical Trial

— RIS-CIT-SCH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893256
• Other study ID #: NFRPA/006/2004
• Status: Completed
• Phase: Phase 4
• First received: May 4, 2009
• Last updated: May 4, 2009
• Start date: December 2004
• Est. completion date: September 2007

Study information

• Verified date: May 2009
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Negative Symptoms
• Schizophrenia

Intervention

Drug:
• Risperidone
Risperidone: tablet; oral; 4-6 mg/day; once daily; 12 weeks
• risperidone
Risperidone: tablet; 4-8 mg/day; once daily; 12 weeks
• Citalopram
Citalopram: tablet; oral; 20 mg/day; once daily; 12 weeks
• Placebo
Placebo: once daily

Locations

Country	Name	City	State
India	National Institute of Mental Health and Neurosciences (NIMHANS)	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health and Neuro Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PANSS negative symptom score		12 weeks	No
Secondary	Change in PANSS total score		12 weeks	No