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OpenTrials
Completed

NCT Number: NCT00893256

Effect of Add-on Citalopram to Risperidone on Negative Symptoms in Schizophrenia

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.

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Key information

Age range

17 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Institute of Mental Health and Neurosciences (NIMHANS)

Bangalore, Karnataka, 560 029, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risperidone

Drug

Risperidone: tablet; oral; 4-6 mg/day; once daily; 12 weeks

Other names: Respidon

Citalopram

Drug

Citalopram: tablet; oral; 20 mg/day; once daily; 12 weeks

Other names: Citopam

Placebo

Drug

Placebo: once daily

Primary outcomes

  1. Change in PANSS negative symptom score

    Time frame: 12 weeks

Secondary outcomes

  1. Change in PANSS total score

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health and Neuro Sciences, India

Other

Registry information

Official study title

Prospective Double-Blind Randomized Comparison Study of Improvement in Negative Symptoms With Risperidone vs Risperidone +Citalopram Combination Therapy in Schizophrenia--a Clinical Study

Acronym: RIS-CIT-SCH

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
May 5, 2009
Registry last updated
May 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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