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

Information source: National Institute of Mental Health and Neuro Sciences, India
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia; Negative Symptoms

Intervention: Risperidone (Drug); risperidone (Drug); Citalopram (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: National Institute of Mental Health and Neuro Sciences, India

Official(s) and/or principal investigator(s):
John P John, M.D., Principal Investigator, Affiliation: National Institute of Mental Health and Neurosciences, Bangalore, INDIA


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.

Clinical Details

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

Primary outcome: Change in PANSS negative symptom score

Secondary outcome: Change in PANSS total score


Minimum age: 17 Years. Maximum age: 50 Years. Gender(s): Both.


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

Locations and Contacts

National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, Karnataka 560 029, India
Additional Information

Starting date: December 2004
Last updated: May 4, 2009

Page last updated: August 23, 2015

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