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

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887679
• Other study ID #: Pro00011288
• Secondary ID: LXP-MD-0148
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2009
• Last updated: October 23, 2014
• Start date: May 2009
• Est. completion date: September 2010

Study information

• Verified date: March 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• HIV Infections

Intervention

Drug:
• Escitalopram
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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Forest Laboratories

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and 7 weeks	No
Primary	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.; 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.	baseline and 7 weeks	No
Secondary	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); = 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	baseline and 7 weeks	No
Secondary	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	baseline to 7 weeks	No
Secondary	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.	baseline and 7 weeks	No
Secondary	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.	baseline and 7 weeks	No