Trial Outcomes & Findings for A Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women (NCT NCT01797380)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

9 weeks.

Results posted on

2013-05-27

Participant Flow

Participant milestones

Participant milestones
Measure	Sugar Pill Placebo	Active Drug Escitalopram tablet, 10mg, daily, 9 weeks.
Overall Study STARTED	3	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugar Pill n=3 Participants Placebo	Active Drug n=2 Participants Escitalopram tablet, 10mg, daily, 9 weeks.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

Adverse Events

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Harold Goforth, M.D.

Duke University Health Systems

Phone: 216-636-3999

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place