DepressionPhase 4NCT01797380

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

A Phase 4 study testing Escitalopram in people with Depression and HIV, run by Duke University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To determine the efficacy of escitalopram in treating depression in HIV seropositive women. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Depression, HIV
What is being tested?: Escitalopram
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 1 siteUnited States
Study dates: Jan 2008to Apr 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 16Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27710

Other trials in United States

About this study

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

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

Read the detailed description

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

Conditions: Depression, HIV
Being tested: Placebo, Escitalopram
Keywords: Depression, HIV
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01797380
Study group	Role	What they receive
Sugar Pill	Placebo comparator	Placebo Receives: Drug: Placebo
Active Drug	Active comparator	Escitalopram tablet, 10mg, daily, 9 weeks. Receives: Drug: Escitalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction in Depressive Symptoms
Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.
Measured: 9 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Apr 2009

First posted22 Feb 2013 (estimated)
Study startJan 2008
Primary completionApr 2009
Study completionApr 2009

Why it stopped: Failure to recruit.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01797380
Sponsor's protocol ID: Pro00000703
Status last verified: Mar 2013
First submitted: 20 Feb 2013
Last updated: 27 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 10491802
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.
PubMed 15123845
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.
PubMed 12809966
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.
PubMed 16375613

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women
ClinicalTrials.gov ID: NCT01797380
Acronym / sponsor ID: Pro00000703
Conditions: Depression, HIV
Keywords: Depression, HIV
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Failure to recruit.
Enrolment: 5 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: Jan 2008
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 22 Feb 2013 (estimated)
Results: Posted 16 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sugar Pill	Placebo comparator	Drug: PlaceboPlacebo
Active Drug	Active comparator	Drug: EscitalopramEscitalopram tablet, 10mg, daily, 9 weeks.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (16 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo daily for duration of double-blind portion of trial	Drug	Sugar Pill
EscitalopramEscitalopram 10 mg po daily for duration of double-blind portion of trial	Drug	Active Drug

Primary outcome

Reduction in Depressive Symptoms
Time frame: 9 weeks.
Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.

Results and safety

Results posted to the registry on 16 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sugar Pill	3	0
Active Drug	2	0

Primary outcome: Reduction in Depressive Symptoms

Time frame: 9 weeks.

Population analysed: Terminated due to lack of recruitment. Five subjects were consented for the trial, but were not able to complete study or generate analyzable data.

Adverse events

Time frame: Study was terminated early due to failure to recruit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sugar Pill	0 of 0	0 of 0	Not reported
Active Drug	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10491802Barroso 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.
Background: PubMed 15123845Currier 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.
Background: PubMed 12809966Gutierrez 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.
Background: PubMed 16375613Himelhoch 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Escitalopram in people with Depression and HIV, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Depressive Symptoms (time frame: 9 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01797380, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2013.