Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00219349
First received: September 14, 2005
Last updated: April 11, 2012
Last verified: April 2012

September 14, 2005
April 11, 2012
January 2005
July 2008   (final data collection date for primary outcome measure)
  • Change in Hamilton Anxiety Rating Scale Score [ Time Frame: week 14 to week 26 ] [ Designated as safety issue: No ]
    The Hamilton Anxiety Rating Scale is a clinician administered rating scale assessing severity of anxiety from 0 (low) to 64 (high). The greater the magnitude of decrease in score during treatment, the greater the improvement in anxiety.
  • Clinical Global Impressions-Improvement Index [ Time Frame: week 26 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions-Severity Index [ Time Frame: week 14 to week 26 ] [ Designated as safety issue: No ]
  • GAD Severity Scale [ Time Frame: week 14 to week 26 ] [ Designated as safety issue: No ]
  • Penn State Worry Questionnaire [ Time Frame: week 14 to week 26 ] [ Designated as safety issue: No ]
  • State-Trait Anxiety Inventory [ Time Frame: week 14 to week 26 ] [ Designated as safety issue: No ]
  • Change in Hamilton Anxiety Scale Score [ Time Frame: week 14 to week 26 ] [ Designated as safety issue: No ]
  • Hamilton Anxiety Rating Scale
  • Clinical Global Impressions-Improvement Index
  • Clinical Global Impressions-Severity Index
  • GAD Severity Scale
  • Penn State Worry Questionnaire
  • State-Trait Anxiety Inventory
  • Structured Clinical Interview for DSM-IV
Complete list of historical versions of study NCT00219349 on ClinicalTrials.gov Archive Site
  • Hamilton Rating Scale for Depression [ Time Frame: week 14 to week 26 ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II [ Time Frame: week 14 to week 26 ] [ Designated as safety issue: No ]
  • Hamilton Rating Scale for Depression
  • Beck Depression Inventory-II
  • Catastrophic Worry Questionnaire
  • Generalized Anxiety Disorder Questionnaire-IV
  • Inventory of Interpersonal Problems
  • Social Problem Solving Inventory – Revised
Not Provided
Not Provided
 
Cognitive-Behavioral Therapy and Escitalopram for Generalized Anxiety Disorder(GAD)
Cognitive-Behavioral Therapy and Pharmacotherapy Augmentation for Generalized Anxiety Disorder: A Pilot Investigation

The goals of this pilot study are as follows:

1) To disseminate and examine the effectiveness of a manualized, individual, cognitive-behavioral psychotherapy (CBT) for adults with Generalized Anxiety Disorder(GAD), 2) to test the effectiveness of augmentation (the addition of) antidepressant therapy in participants who do not fully respond to CBT, and 3) to examine individual and clinical predictors of non-response to CBT and predictors of response to augmentation antidepressant therapy. A related goal is to examine the maintenance of treatment gains obtained from CBT alone and CBT with augmentation antidepressant therapy, over a twenty-four month follow-up period. This study will serve as a pilot investigation in preparation for a larger federally funded study using this treatment approach. We hypothesize that CBT will result in remission (no longer having GAD) and/or high endstate functioning (clinically meaningful improvement) in approximately 40-50% of participants. Further, we hypothesize that augmentation antidepressant therapy in participants who do not fully respond to CBT will result in further clinically significant improvement.

This pilot investigation will examine the effectiveness of augmenting cognitive behavioral therapy (CBT) with antidepressant pharmacotherapy (escitalopram[Lexapro]) in adults with generalized anxiety disorder (GAD) who do not fully respond to a temporally primary trial of CBT. A secondary aim of this study is to assess the maintenance of treatment gains made by patients in response to CBT, and to CBT with antidepressant augmentation therapy, over a two-year follow-up period.

CBT is an empirically supported psychotherapy that has been found to be effective in treating GAD in approximately 50 percent of patients enrolled in controlled clinical trials. However, a substantial proportion (nearly half) of individuals with GAD do not achieve full remission or clinically significant improvement at the cessation of CBT. Escitalopram (Lexapro)is a selective serotonin reuptake inhibitor (SSRI) antidepressant, which has been shown to be effective in treating GAD in several large-scale controlled clinical trials. The Food and Drug Administration has approved ecitalopram for the treatment of GAD.

The proposed research plan encompasses the conduct of an open clinical trial (No randomized placebo control) of 14 sessions of manualized individual CBT for persons meeting DSM-IV-TR diagnostic criteria for GAD. This study will use a treatment manual developed by Dr. Thomas Borkovec and colleagues at the Pennsylvania State University. Participants who meet high endstate functioning criteria and/or achieve remission following CBT will be evaluated periodically during a twenty-four month follow-up phase. Participants who do not meet high endstate functioning criteria and/or achieve remission following completion of CBT will be offered entry into a twelve-week, open-label, flexible-dose trial of escitalopram therapy. Participants receiving escitalopram therapy will be evaluated periodically during a twenty-four month follow-up phase, as well. It is anticipated that patients who do not fully respond to CBT will show a significant increment in improvement in GAD symptoms, over and above their CBT posttreatment level, following pharmacotherapy with escitalopram.

At present, no studies with GAD populations have examined the additive or sequenced effects of psychosocial therapy and SSRI antidepressant pharmacotherapy. The proposed research is a first step in this direction and may provide evidence supporting the use of combined treatment modalities in CBT partial and non-responders.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • Behavioral: Cognitive Behavioral-Therapy
    14 weekly sessions of individualized CBT
  • Drug: escitalopram
    10-20 mg per day for 12 weeks
    Other Name: lexapro
Not Provided
Schneier FR, Belzer KD, Kishon R, Amsel L, Simpson HB. Escitalopram for persistent symptoms of generalized anxiety disorder after CBT: a pilot study. J Nerv Ment Dis. 2010 Jun;198(6):458-61. doi: 10.1097/NMD.0b013e3181da4d77. PubMed PMID: 20531128.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males or females between the ages of 18 and 65 (inclusive)
  2. Primary DSM-IV-TR diagnosis of Generalized Anxiety Disorder (GAD) with no significant co-morbid anxiety disorder for which CBT for GAD is not appropriate including PTSD, OCD, and prominent panic disorder with or without agoraphobia
  3. A negative urine toxicology, i.e., a urine specimen that does not test positive for use of drugs of abuse, or use of benzodiazepines, in the previous three weeks
  4. Penn State Worry Questionnaire score of 55 or greater
  5. Have a score of equal to or > 4 (Moderately Ill) on Clinical Global Impression (CGI) Scale (severity of illness item) for GAD
  6. Ability to give informed consent
  7. Fluent in English
  8. Willingness to have Cognitive-Behavioral Therapy sessions audiotaped -

Exclusion Criteria:

  1. Patients who have a diagnosis of Major Depressive Disorder within 60 days prior to the clinical interview, and patients who have a "lifetime" history of being diagnosed with one or more of the following disorders: Schizophrenia, Major Depressive Disorder with Psychotic or Catatonic features, Bipolar I Affective Disorder, or Organic Mental Disease
  2. DSM-IV substance abuse or dependence within the past 6 months (except nicotine or caffeine)
  3. Active suicidal or homicidal ideation, or judged to be at serious suicide risk
  4. Hamilton Rating Scale for Depression score of greater than 20 at Screening or Baseline evaluation
  5. Any unstable medical or neurological condition
  6. Women who are pregnant or lactating
  7. Having received CBT treatment for GAD previously
  8. Concurrent psychosocial therapy
  9. Current psychotropic medication with exception of zolpidem at hs for insomnia
  10. History of nonresponse to an adequate trial of escitalopram or intolerable adverse effects to escitalopram -
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00219349
#4941
No
New York State Psychiatric Institute
New York State Psychiatric Institute
Forest Laboratories
Principal Investigator: Franklin R. Schneier, M.D. New York State Psychiatric Institute
Principal Investigator: Kenneth D Belzer, Ph.D. New York State Psychiatric Institute
New York State Psychiatric Institute
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP