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Failure to recruit.
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To determine the efficacy of escitalopram in treating depression in HIV seropositive women.
To determine the efficacy of escitalopram in treating depression in HIV seropositive women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar Pill | Placebo Comparator | Placebo |
|
| Active Drug | Active Comparator | Escitalopram tablet, 10mg, daily, 9 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo daily for duration of double-blind portion of trial |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Depressive Symptoms | Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks. | 9 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10491802 | Background | 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. | |
| 15123845 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugar Pill | Placebo |
| FG001 | Active Drug | Escitalopram tablet, 10mg, daily, 9 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Terminated study. Study terminated prior to interventions
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugar Pill | Placebo |
| BG001 | Active Drug | Escitalopram tablet, 10mg, daily, 9 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction in Depressive Symptoms | Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks. | Terminated due to lack of recruitment. Five subjects were consented for the trial, but were not able to complete study or generate analyzable data. | Posted | 9 weeks. |
|
Study was terminated early due to failure to recruit.
Study was terminated before adverse events were noted.No participants were treated therefore no participants were analyzed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugar Pill | Placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harold Goforth, M.D. | Duke University Health Systems | 216-636-3999 | goforth@ccf.org |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Escitalopram |
| Drug |
Escitalopram 10 mg po daily for duration of double-blind portion of trial |
|
| 12809966 | Background | 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. |
| 16375613 | Background | 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. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Active Drug | Escitalopram tablet, 10mg, daily, 9 weeks. | 0 | 0 | 0 | 0 |
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |