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

• ClinicalTrials.gov Identifier: NCT00887679
• Recruitment Status: Completed
• First Posted: April 24, 2009
• Results First Posted: March 10, 2014
• Last Update Posted: October 31, 2014
• Sponsor: Duke University
• Collaborator: Forest Laboratories
• Information provided by (Responsible Party): Duke University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Anxiety Disorders; HIV Infections	Drug: Escitalopram	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Study Start Date: May 2009
• Actual Primary Completion Date: September 2009
• Actual Study Completion Date: September 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Escitalopram; Treatment 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.	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.

Outcome Measures

Primary Outcome Measures :

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.

   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.

Secondary Outcome Measures :

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)

   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
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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Forest Laboratories

Investigators

• Principal Investigator: Ashwin A Patkar, MD; Duke University

More Information

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.

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.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00887679 History of Changes
• Other Study ID Numbers: Pro00011288; LXP-MD-0148
• First Posted: April 24, 2009
• Results First Posted: March 10, 2014
• Last Update Posted: October 31, 2014
• Last Verified: March 2014

Keywords provided by Duke University:

Escitalopram; Anxiety Disorder; HIV and AIDS; treatment experienced

Additional relevant MeSH terms:

Dexetimide; Citalopram; Disease; Anxiety Disorders; Pathologic Processes; Mental Disorders; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Antiparkinson Agents; Anti-Dyskinesia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents