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Completed

NCT Number: NCT00887679

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

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.

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Key information

Conditions

Anxiety Disorders Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Escitalopram

Drug

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.

Primary outcomes

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

    Time frame: baseline and 7 weeks

    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.

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

    Time frame: baseline and 7 weeks

    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.

    • I feel sad.
    • I am sad all the time and I can't snap out of it.
    • 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.

Secondary outcomes

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

    Time frame: baseline and 7 weeks

    Scale for scoring:

    Clinical Global Impression(CGI-S)

    • = Normal, no symptoms
    • = Borderline ill
    • = Mildly ill
    • = Moderately ill
    • = Markedly ill
    • = Severely ill
    • = Most extremely ill

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

    • very much improved
    • much improved
    • minimally improved
    • no change from baseline
    • minimally worse
    • much worse
    • very much worse

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

    Time frame: baseline to 7 weeks

    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

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

    Time frame: baseline and 7 weeks

    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.

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

    Time frame: baseline and 7 weeks

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Forest Laboratories

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Apr 24, 2009
Registry last updated
Oct 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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