Depression, HIV
Conditions
Keywords
Depression, HIV
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.
Interventions
DRUGPlacebo
Placebo daily for duration of double-blind portion of trial
DRUGEscitalopram
Escitalopram 10 mg po daily for duration of double-blind portion of trial
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Depressive Symptoms | 9 weeks. | Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sugar Pill Placebo | 3 |
| Active Drug Escitalopram tablet, 10mg, daily, 9 weeks. | 2 |
| Total | 5 |
Baseline characteristics
| Characteristic | Total | Sugar Pill | Active Drug |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 2 Participants |
| Region of Enrollment United States | 5 participants | 3 participants | 2 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Reduction in Depressive Symptoms
Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.
Time frame: 9 weeks.
Population: Terminated due to lack of recruitment. Five subjects were consented for the trial, but were not able to complete study or generate analyzable data.