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Antidepressant Treatment in Older Adults With Schizophrenia

NCT ID: NCT00047450

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2007-09-30

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of citalopram (Celexa) for the treatment of depressive symptoms in middle-aged and elderly patients with schizophrenia.

Detailed Description

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Older people with schizophrenia suffer from greater physical comorbidity, cognitive impairment, and medication side effects compared to their younger counterparts. Unfortunately, little research is available to guide the treatment of subsyndromal depressive symptoms in older adults. This study will compare the antidepressant citalopram to placebo to determine the most effective treatment for reducing depressive symptoms in older patients with schizophrenia

After patients have been on stable treatment with antipsychotic medication for at least 4 weeks, they are randomly assigned to receive antipsychotic medication plus either citalopram or placebo for 3 months. Depressive symptoms and side effects are assessed weekly for the first month, biweekly for the second month, and again at the end of the third month. Cognition, motor and daily functioning, quality of life, and medication adherence are assessed throughout the study.

Conditions

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Schizophrenia

Keywords

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Psychotic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Participants will take placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for 3 months

2

Participants will take citalopram (Celexa)

Group Type ACTIVE_COMPARATOR

Citalopram (Celexa)

Intervention Type DRUG

Citalopram for 3 months

Interventions

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Citalopram (Celexa)

Citalopram for 3 months

Intervention Type DRUG

Placebo

Placebo for 3 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Schizophrenia or schizoaffective disorder
* HAM-D score of 8 or above
* Antipsychotic medication treatment
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Veterans Medical Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Sidney Zisook

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sidney Zisook, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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San Diego VA Medical Center

San Diego, California, United States

Site Status

Veterans Administration Hospital of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Zisook S, Kasckow JW, Lanouette NM, Golshan S, Fellows I, Vahia I, Mohamed S, Rao S. Augmentation with citalopram for suicidal ideation in middle-aged and older outpatients with schizophrenia and schizoaffective disorder who have subthreshold depressive symptoms: a randomized controlled trial. J Clin Psychiatry. 2010 Jul;71(7):915-22. doi: 10.4088/JCP.09m05699gre. Epub 2010 Mar 9.

Reference Type DERIVED
PMID: 20361918 (View on PubMed)

Zisook S, Kasckow JW, Golshan S, Fellows I, Solorzano E, Lehman D, Mohamed S, Jeste DV. Citalopram augmentation for subsyndromal symptoms of depression in middle-aged and older outpatients with schizophrenia and schizoaffective disorder: a randomized controlled trial. J Clin Psychiatry. 2009 Apr;70(4):562-71. doi: 10.4088/jcp.08m04261. Epub 2008 Dec 16.

Reference Type DERIVED
PMID: 19192468 (View on PubMed)

Other Identifiers

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R01MH063931

Identifier Type: NIH

Identifier Source: secondary_id

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DATR A4-GPX

Identifier Type: -

Identifier Source: secondary_id

R01MH063931

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT00046098

Identifier Type: -

Identifier Source: nct_alias