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Sponsored by: |
National Institute of Mental Health and Neuro Sciences, India |
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Information provided by: | National Institute of Mental Health and Neuro Sciences, India |
ClinicalTrials.gov Identifier: | NCT00893256 |
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 |
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Schizophrenia Negative Symptoms |
Drug: Risperidone Drug: risperidone Drug: Citalopram Drug: Placebo |
Phase IV |
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 |
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 |
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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)
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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
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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)
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Drug: risperidone
Risperidone: tablet; 4-8 mg/day; once daily; 12 weeks
Drug: Placebo
Placebo: once daily
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Ages Eligible for Study: | 17 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India, Karnataka | |
National Institute of Mental Health and Neurosciences (NIMHANS) | |
Bangalore, Karnataka, India, 560 029 |
Principal Investigator: | John P John, M.D. | National Institute of Mental Health and Neurosciences, Bangalore, INDIA |
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 |
schizophrenia risperidone citalopram secondary negative symptoms |
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 |
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 |