Negative Symptoms, Schizophrenia
Conditions
Keywords
schizophrenia, risperidone, citalopram, secondary negative symptoms
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.
Interventions
DRUGRisperidone
Risperidone: tablet; oral; 4-6 mg/day; once daily; 12 weeks
DRUGrisperidone
Risperidone: tablet; 4-8 mg/day; once daily; 12 weeks
DRUGCitalopram
Citalopram: tablet; oral; 20 mg/day; once daily; 12 weeks
DRUGPlacebo
Placebo: once daily
Sponsors
National Institute of Mental Health and Neuro Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in PANSS negative symptom score | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in PANSS total score | 12 weeks |
Countries
India
Outcome results
None listed