NCT00893256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Dec 2004

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
Last Updated

May 5, 2009

Status Verified

May 1, 2009

Enrollment Period

2.8 years

First QC Date

May 4, 2009

Last Update Submit

May 4, 2009

Conditions

SchizophreniaNegative Symptoms

Keywords

schizophreniarisperidonecitalopramsecondary negative symptoms

Outcome Measures

Primary Outcomes (1)

  • Change in PANSS negative symptom score

    12 weeks

Secondary Outcomes (1)

  • Change in PANSS total score

    12 weeks

Study Arms (2)

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)

Drug: RisperidoneDrug: Citalopram

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)

Drug: risperidoneDrug: Placebo

Interventions

risperidoneDRUG

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

Also known as: Respidon
Risperidone and citalopram
CitalopramDRUG

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

Also known as: Citopam
Risperidone and citalopram
PlaceboDRUG

Placebo: once daily

Risperidone and placebo

Eligibility Criteria

Age17 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health and Neurosciences (NIMHANS)

Bangalore, Karnataka, 560 029, India

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

RisperidoneCitalopram

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • John P John, M.D.

    National Institute of Mental Health and Neurosciences, Bangalore, INDIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 5, 2009

Study Start

December 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

May 5, 2009

Record last verified: 2009-05

Locations

IN(1)