Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia
- Conditions
- SchizophreniaNegative Symptoms
- Interventions
- Registration Number
- NCT00893256
- Lead Sponsor
- National Institute of Mental Health and Neuro Sciences, India
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Risperidone and placebo 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) Risperidone and citalopram risperidone 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) Risperidone and citalopram 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) Risperidone and placebo risperidone 24 patients were randomized to receive add-on placebo in a double-blind fashion to open-label treatment with risperidone (4-8 mg/day)
- Primary Outcome Measures
Name Time Method Change in PANSS negative symptom score 12 weeks
- Secondary Outcome Measures
Name Time Method Change in PANSS total score 12 weeks
Trial Locations
- Locations (1)
National Institute of Mental Health and Neurosciences (NIMHANS)
🇮🇳Bangalore, Karnataka, India