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A Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women

Primary Purpose

Depression, HIV

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Placebo

Escitalopram

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, HIV

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of major depression based on DSM-IV criteria;
age 18-70 years;
Greater than 15 on MADRS for severity of depression;
HIV seropositive;
no new antiviral medications over the past 2 months;
involved in active treatment for HIV disease,
negative serum pregnancy test
Those subjects who are actively being treated for depression but show no improvement as defined by self-reported failure to improve with current treatment or residual depression as demonstrated by a MADRS of 15 or greater will be asked to participate in the study as well.

Exclusion Criteria:

The presence of an active and significant psychiatric disease other than Major Depressive Disorder as diagnosed on MINI in the last 3 months;
meeting DSM-IV criteria for an Axis I disorder within the last three months, or meeting criteria for substance abuse within the last 12 months;
current pregnancy or lactation if breast feeding;
history of hypersensitivity, intolerance, or contraindication to LEX;
baseline creatinine of 2.5 or greater;
patients taking anticoagulants;
history of diagnosed gastric or duodenal ulcer;
history within past year of bleeding or clotting diathesis;
lifetime history of myocardial infarction or cerebrovascular accident;
history of surgery within the past 3 months;
inability to follow study procedures or complete the study;
the use of any antidepressant medications within 5 half-lives of randomization;
women of child-bearing potential who will not agree to use approved means of birth control during the trial;
other reason that the primary investigator believes that the subject will be unable to complete trial or has medical/psychiatric contraindications to the trial.
Individuals who are currently being treated for depression and show significant improvements in their depression such that discontinuing their current antidepressant therapy would likely have negative clinical consequences will be excluded from participating in this study.
Individuals who are or become suicidal will be excluded from this study.

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sugar Pill

Active Drug

Arm Description

Placebo

Escitalopram tablet, 10mg, daily, 9 weeks.

Outcomes

Primary Outcome Measures

Reduction in Depressive Symptoms

Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.

Secondary Outcome Measures

Full Information

NCT ID

NCT01797380

First Posted

February 20, 2013

Last Updated

May 17, 2013

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT01797380

Brief Title

A Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women

Official Title

A Double-Blind, Placebo-Controlled Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Terminated

Why Stopped

Failure to recruit.

Study Start Date

January 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To determine the efficacy of escitalopram in treating depression in HIV seropositive women.

Detailed Description

To determine the efficacy of escitalopram in treating depression in HIV seropositive women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, HIV

Keywords

Depression, HIV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sugar Pill

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Active Drug

Arm Type

Active Comparator

Arm Description

Escitalopram tablet, 10mg, daily, 9 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo daily for duration of double-blind portion of trial

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Intervention Description

Escitalopram 10 mg po daily for duration of double-blind portion of trial

Primary Outcome Measure Information:

Title

Reduction in Depressive Symptoms

Description

Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.

Time Frame

9 weeks.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of major depression based on DSM-IV criteria; age 18-70 years; Greater than 15 on MADRS for severity of depression; HIV seropositive; no new antiviral medications over the past 2 months; involved in active treatment for HIV disease, negative serum pregnancy test Those subjects who are actively being treated for depression but show no improvement as defined by self-reported failure to improve with current treatment or residual depression as demonstrated by a MADRS of 15 or greater will be asked to participate in the study as well. Exclusion Criteria: The presence of an active and significant psychiatric disease other than Major Depressive Disorder as diagnosed on MINI in the last 3 months; meeting DSM-IV criteria for an Axis I disorder within the last three months, or meeting criteria for substance abuse within the last 12 months; current pregnancy or lactation if breast feeding; history of hypersensitivity, intolerance, or contraindication to LEX; baseline creatinine of 2.5 or greater; patients taking anticoagulants; history of diagnosed gastric or duodenal ulcer; history within past year of bleeding or clotting diathesis; lifetime history of myocardial infarction or cerebrovascular accident; history of surgery within the past 3 months; inability to follow study procedures or complete the study; the use of any antidepressant medications within 5 half-lives of randomization; women of child-bearing potential who will not agree to use approved means of birth control during the trial; other reason that the primary investigator believes that the subject will be unable to complete trial or has medical/psychiatric contraindications to the trial. Individuals who are currently being treated for depression and show significant improvements in their depression such that discontinuing their current antidepressant therapy would likely have negative clinical consequences will be excluded from participating in this study. Individuals who are or become suicidal will be excluded from this study.

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10491802

Citation

Barroso J. A review of fatigue in people with HIV infection. J Assoc Nurses AIDS Care. 1999 Sep-Oct;10(5):42-9. doi: 10.1016/S1055-3290(06)60342-7.

Results Reference

background

PubMed Identifier

15123845

Citation

Currier MB, Molina G, Kato M. Citalopram treatment of major depressive disorder in Hispanic HIV and AIDS patients: a prospective study. Psychosomatics. 2004 May-Jun;45(3):210-6. doi: 10.1176/appi.psy.45.3.210.

Results Reference

background

PubMed Identifier

12809966

Citation

Gutierrez MM, Rosenberg J, Abramowitz W. An evaluation of the potential for pharmacokinetic interaction between escitalopram and the cytochrome P450 3A4 inhibitor ritonavir. Clin Ther. 2003 Apr;25(4):1200-10. doi: 10.1016/s0149-2918(03)80076-0.

Results Reference

background

PubMed Identifier

16375613

Citation

Himelhoch S, Medoff DR. Efficacy of antidepressant medication among HIV-positive individuals with depression: a systematic review and meta-analysis. AIDS Patient Care STDS. 2005 Dec;19(12):813-22. doi: 10.1089/apc.2005.19.813.

Results Reference

background

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A Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women

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