Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia (RIS-CIT-SCH)
Primary Purpose
Schizophrenia, Negative Symptoms
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Risperidone
risperidone
Citalopram
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, risperidone, citalopram, secondary negative symptoms
Eligibility 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
Sites / Locations
- National Institute of Mental Health and Neurosciences (NIMHANS)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Risperidone and citalopram
Risperidone and placebo
Arm Description
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)
24 patients were randomized to receive add-on placebo in a double-blind fashion to open-label treatment with risperidone (4-8 mg/day)
Outcomes
Primary Outcome Measures
Change in PANSS negative symptom score
Secondary Outcome Measures
Change in PANSS total score
Full Information
NCT ID
NCT00893256
First Posted
May 4, 2009
Last Updated
May 4, 2009
Sponsor
National Institute of Mental Health and Neuro Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT00893256
Brief Title
Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Mental Health and Neuro Sciences, India
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Negative Symptoms
Keywords
schizophrenia, risperidone, citalopram, secondary negative symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risperidone and citalopram
Arm Type
Experimental
Arm Description
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)
Arm Title
Risperidone and placebo
Arm Type
Placebo Comparator
Arm Description
24 patients were randomized to receive add-on placebo in a double-blind fashion to open-label treatment with risperidone (4-8 mg/day)
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Respidon
Intervention Description
Risperidone: tablet; oral; 4-6 mg/day; once daily; 12 weeks
Intervention Type
Drug
Intervention Name(s)
risperidone
Other Intervention Name(s)
Respidon
Intervention Description
Risperidone: tablet; 4-8 mg/day; once daily; 12 weeks
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
Citopam
Intervention Description
Citalopram: tablet; oral; 20 mg/day; once daily; 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo: once daily
Primary Outcome Measure Information:
Title
Change in PANSS negative symptom score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in PANSS total score
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P John, M.D.
Organizational Affiliation
National Institute of Mental Health and Neurosciences, Bangalore, INDIA
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Mental Health and Neurosciences (NIMHANS)
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 029
Country
India
12. IPD Sharing Statement
Learn more about this trial
Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia
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