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Anxiety DisordersPhase 3NCT00887679

Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS

A Phase 3 study testing Escitalopram in people with Anxiety Disorders and HIV Infections, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate whether escitalopram is safe, well tolerated, and effective in the treatment of HIV-infected patients with generalized anxiety disorder. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Anxiety Disorders, HIV Infections
What is being tested?
Escitalopram
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
May 2009to Sep 2010
Phase
Phase 3
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age 18 to 65 years,
  • DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for Generalized Anxiety Disorder
  • confirmed stable HIV disease and attending a HIV treatment program
  • stable dose of highly active anti-retroviral therapy for a minimum of 4 weeks
  • ability to give informed consent

Who cannot join

  • bipolar disorders, any psychotic disorder
  • current major depression
  • substance dependence (except nicotine dependence) in the previous 3 months
  • currently suicidal or high suicide risk, serious or unstable medical disorders (e.g. uncontrolled hypertension or diabetes)
  • any hospitalization for HIV-related illness in the previous 3 months
  • any active CNS (central nervous system) CNS opportunistic infection or CNS malignancies related to HIV
Show all 14Show fewer
  • current active treatment for opportunistic infections related to HIV
  • any psychotropic drug treatment in the previous 2 weeks before screening
  • history of hypersensitivity to escitalopram and/or citalopram
  • admission BDI 23
  • seizure disorder, traumatic brain injury
  • pregnant, nursing mother or planning to get pregnant.
  • Concomitant mediations: At least 2-week washout of antidepressant (4 weeks for fluoxetine) or antipsychotic or anti-anxiety medications.
  • In the opinion of the investigator the clinical condition precludes participation in the trial.

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: Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder, Adherence to Antiretroviral Therapy,Cognition, and Immune Status Among Patients With HIV and AIDS: A 6-week Open-label, Prospective, Pilot Trial.

The purpose of this study is to evaluate whether escitalopram is safe, well tolerated, and effective in the treatment of HIV-infected patients with generalized anxiety disorder.

Read the detailed description

Anxiety disorders are twice as prevalent among HIV-infected patients as they are in the general population. Approximately 25%-40% of HIV-infected patients have anxiety disorders; Generalized Anxiety Disorder, Panic disorder and post-traumatic Stress Disorder being the most frequent. Non-adherence to anti-retroviral medications is commonly seen in patients with HIV with GAD.The role of specific selective serotonin reuptake (SSRIs) in the treatment of HIV-patients with GAD is unclear. Escitalopram has been used in the treatment of GAD in the general population. It has been shown to be safe in HIV-patients with a tolerable side-effect profile. However, whether it can improve GAD in HIV-infected patients has not yet been investigated.

Being tested
Escitalopram
Keywords
Escitalopram, Anxiety Disorder, HIV and AIDS, treatment experienced
Medical subject headings
Anxiety Disorders, HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

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

  • EscitalopramDrug

    10-20 mg/day oral of Escitalopram for 6-weeks. Escitalopram flexible dose (10-20 mg/day). A forced escalation schedule of escitalopram was used to titrate it to the maximum tolerated dose. Drug was discontinued at the end of the study.

Study groups in NCT00887679
Study groupRoleWhat they receive
EscitalopramExperimentalTreatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Open label, rater-blinded, prospective, 6-week trial of escitalopram.Subjects received escitalopram 10-20mg. Escitalopram was started at 10mg per day and augmented weekly in 10mg per day increments, the maximum dose being 20mg per day.
Receives: Drug: Escitalopram

What is being measured

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

  1. Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)

    The HAM-A is administered by an interviewer who asks a series of questions related to symptoms of anxiety. The interviewer then rates the individual on a five-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining seven items address somatic anxiety. The total anxiety score ranges from 0 to 56, lower scores are better. Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A)is measured.

    Measured: baseline and 7 weeks

  2. Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory

    Scoring

    The BDI consist of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity as follows:

    (0) I do not feel sad.

    1. I feel sad.
    2. I am sad all the time and I can't snap out of it.
    3. I am so sad or unhappy that I can't stand it.

    A value of 0 to 3 is assigned for each answer and the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[6] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.

    Higher total scores indicate more severe depressive symptoms.

    Measured: baseline and 7 weeks

Secondary outcomes (4)

  1. Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)

    Scale for scoring:

    Clinical Global Impression(CGI-S)

    1. = Normal, no symptoms
    2. = Borderline ill
    3. = Mildly ill
    4. = Moderately ill
    5. = Markedly ill
    6. = Severely ill
    7. = Most extremely ill

    Clinical Global Impression(CGI-I)-improvement since treatment

    1. very much improved
    2. much improved
    3. minimally improved
    4. no change from baseline
    5. minimally worse
    6. much worse
    7. very much worse

    Measured: baseline and 7 weeks

  2. Change From Randomization to End of Treatment for Trail Making Tet (TMT)

    Trail Making Test (TMT)Results for TMT are reported as the number of seconds required to complete the task. Higher scores reveal greater impairment.

    Average =29 seconds, Deficient > 78 seconds

    Measured: baseline to 7 weeks

  3. Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)

    Mini Mental State Examination (MMSE),a low score less than or equal to 23 indicates cognitive impairment and the need for further evaluation; normal cognitive function = 27-30, mild cognitive impairment = 21-26, moderate cognitive impairment = 11-20, and severe cognitive impairment = 0-10. The highest possible score is 30.

    Measured: baseline and 7 weeks

  4. Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)

    Scoring:

    Participants rate the extent to which work, social life, and home life are impaired by his or her symptoms. A 10 point scale is used where 0= not impaired and 10 is highly impaired indicating. The three aspects of life can be summed up into a single dimensional measure of global functional impairment that indicates 0= not impaired and 30 = highly impaired. Scores of 5 or greater are on any of the three scales are considered significant.

    Measured: baseline and 7 weeks

Timeline

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

  1. First posted24 Apr 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionSep 2009
  4. Study completionSep 2010

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00887679
Sponsor's protocol ID
Pro00011288
Other IDs
LXP-MD-0148
Status last verified
Mar 2014
First submitted
23 Apr 2009
Last updated
31 Oct 2014
Data monitoring committee
No

Publications

  • Pence BW, Miller WC, Whetten K, Eron JJ, Gaynes BN. Prevalence of DSM-IV-defined mood, anxiety, and substance use disorders in an HIV clinic in the Southeastern United States. J Acquir Immune Defic Syndr. 2006 Jul;42(3):298-306. doi: 10.1097/01.qai.0000219773.82055.aa.

    PubMed 16639343

  • Tucker JS, Kanouse DE, Miu A, Koegel P, Sullivan G. HIV risk behaviors and their correlates among HIV-positive adults with serious mental illness. AIDS Behav. 2003 Mar;7(1):29-40. doi: 10.1023/a:1022557222690.

    PubMed 14534388

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Escitalopram in people with Anxiety Disorders and HIV Infections, 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 31 Oct 2014. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 10 Mar 2014). 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?

Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A) (time frame: baseline and 7 weeks). The study lists 2 primary outcomes in all. 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 NCT00887679, which also lists 2 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 31 Oct 2014.

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