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Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia (RIS-CIT-SCH)
This study has been completed.
First Received: May 4, 2009   No Changes Posted
Sponsored by: National Institute of Mental Health and Neuro Sciences, India
Information provided by: National Institute of Mental Health and Neuro Sciences, India
ClinicalTrials.gov Identifier: NCT00893256
  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 IV

MedlinePlus related topics: Child Mental Health Mental Health Schizophrenia
Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Risperidone Escitalopram Escitalopram oxalate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

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
Risperidone and citalopram: Experimental
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
Drug: Citalopram
Citalopram: tablet; oral; 20 mg/day; once daily; 12 weeks
Risperidone and placebo: Placebo Comparator
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
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, Karnataka
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: NIMHANS ( Dean )
Study ID Numbers: NFRPA/006/2004
Study First Received: May 4, 2009
Last Updated: May 4, 2009
ClinicalTrials.gov Identifier: NCT00893256     History of Changes
Health Authority: India: Institutional Review Board

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

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Cholinergic Antagonists
Risperidone
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Cholinergic Agents
Citalopram
Serotonin Uptake Inhibitors
Serotonin
Muscarinic Antagonists
Schizophrenia
Dopamine
Mental Disorders
Neoplasm Metastasis
Dopamine Agents
Psychotic Disorders
Peripheral Nervous System Agents
Dexetimide
Antidepressive Agents, Second-Generation
Schizophrenia and Disorders with Psychotic Features
Antidepressive Agents

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

ClinicalTrials.gov processed this record on May 07, 2009