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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health and Neuro Sciences, India
ClinicalTrials.gov Identifier:
NCT00893256
First received: May 4, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention Phase
Schizophrenia
Negative Symptoms
Drug: Risperidone
Drug: risperidone
Drug: Citalopram
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health and Neuro Sciences, India:

Primary Outcome Measures:
  • Change in PANSS negative symptom score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in PANSS total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: December 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Respidon
Drug: Citalopram
Citalopram: tablet; oral; 20 mg/day; once daily; 12 weeks
Other Name: 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 Name: Respidon
Drug: Placebo
Placebo: once daily

  Eligibility

Ages Eligible for Study:   17 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893256

Locations
India
National Institute of Mental Health and Neurosciences (NIMHANS)
Bangalore, Karnataka, India, 560 029
Sponsors and Collaborators
National Institute of Mental Health and Neuro Sciences, India
Investigators
Principal Investigator: John P John, M.D. National Institute of Mental Health and Neurosciences, Bangalore, INDIA
  More Information

No publications provided

Responsible Party: Dean, NIMHANS
ClinicalTrials.gov Identifier: NCT00893256     History of Changes
Other Study ID Numbers: NFRPA/006/2004
Study First Received: May 4, 2009
Last Updated: May 4, 2009
Health Authority: India: Institutional Review Board

Keywords provided by National Institute of Mental Health and Neuro Sciences, India:
schizophrenia
risperidone
citalopram
secondary negative symptoms

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Citalopram
Dexetimide
Risperidone
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Serotonin Antagonists
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 17, 2014