Clinical trial NCT00893256: Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Negative Symptoms
Keywords: schizophrenia
risperidone
citalopram
secondary negative symptoms
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2009-05-05
Enrollment: 48
Sex: ALL
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in PANSS negative symptom score
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in PANSS total score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bangalore
country: India
facility: National Institute of Mental Health and Neurosciences (NIMHANS)
state: Karnataka
Study officials:
affiliation: National Institute of Mental Health and Neurosciences, Bangalore, INDIA
name: John P John, M.D.
role: PRINCIPAL_INVESTIGATOR
References: