Antidepressant Treatment in Older Adults With Schizophrenia - Tabular View

Tracking Information

First Received Date ^ICMJE

October 4, 2002

Last Updated Date

March 4, 2008

Start Date ^ICMJE

September 2001

Estimated Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00047450 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Antidepressant Treatment in Older Adults With Schizophrenia

Official Title ^ICMJE

Citalopram Augmentation in Older Patients With Schizophrenia

Brief Summary

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Citalopram (Celexa)
Drug: Placebo

Study Arms / Comparison Groups

Placebo Comparator: Participants will take placebo
Active Comparator: Participants will take citalopram (Celexa)

Publications *

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. Epub 2008 Dec 16.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

212

Completion Date

September 2007

Estimated Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Schizophrenia or schizoaffective disorder
HAM-D score of 8 or above
Antipsychotic medication treatment

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00047450

Responsible Party

Sidney Zisook, MD, UCSD

Study ID Numbers ^ICMJE

R01 MH63931, DATR A4-GPX

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Sidney Zisook, MD

University of California, San Diego

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP