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

NCT00219349 | Completed Phase 4 Results

• 1 other identifier: #4941
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Generalized Anxiety Disorder

Keywords

Anxiety Disorders; Anxiety Neuroses; Behavior Therapy, Cognitive; Escitalopram

Outcome Measures

Primary Outcomes (5)

• Change in Hamilton Anxiety Rating Scale Score

  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.

  week 14 to week 26

• Change in Clinical Global Impressions-Severity Index

  7 point scale of overall severity of psychopathology from 1 mildest to 7 most severe.

  week 14 to week 26

• Change in Generalized Anxiety Disorder Severity Scale

  measures severity of symptoms of generalized anxiety disorder, reported as a total score summing 10 items that are each rated from 0, never to 4, all of the time. Range is 0 to 40, with 40 most severe.

  week 14 to week 26

• Change in Penn State Worry Questionnaire

  total score (of 16 items) ranging from 16 (least worry) to 80 (most worry)

  week 14 to week 26

• Change in State-Trait Anxiety Inventory, State Subscale

  only the total score of the state anxiey subscale was used. Range is from 20 (mildest) to 80 (most severe)

  week 14 to week 26

Secondary Outcomes (3)

• Clinical Global Impressions-Improvement Index

  week 26

• Change in Hamilton Rating Scale for Depression

  week 14 to week 26

• Change in Beck Depression Inventory-II

  week 14 to week 26

Study Arms (1)

Escitalopram

EXPERIMENTAL

12 weeks of open label escitalopram, 10-20 mg/day (after 14 weeks of cognitive behavioral therapy

Behavioral: Cognitive Behavioral Therapy; Drug: escitalopram

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

14 weekly sessions of individualized CBT

Escitalopram

escitalopram DRUG

10-20 mg per day for 12 weeks

Also known as: lexapro

Escitalopram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between the ages of 18 and 65 (inclusive)
• 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
• 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
• Penn State Worry Questionnaire score of 55 or greater
• Have a score of equal to or \> 4 (Moderately Ill) on Clinical Global Impression (CGI) Scale (severity of illness item) for GAD
• Ability to give informed consent
• Fluent in English
• Willingness to have Cognitive-Behavioral Therapy sessions audiotaped -

You may not qualify if:

• 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
• DSM-IV substance abuse or dependence within the past 6 months (except nicotine or caffeine)
• Active suicidal or homicidal ideation, or judged to be at serious suicide risk
• Hamilton Rating Scale for Depression score of greater than 20 at Screening or Baseline evaluation
• Any unstable medical or neurological condition
• Women who are pregnant or lactating
• Having received CBT treatment for GAD previously
• Concurrent psychosocial therapy
• Current psychotropic medication with exception of zolpidem at hs for insomnia
• History of nonresponse to an adequate trial of escitalopram or intolerable adverse effects to escitalopram -

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Forest Laboratories: collaborator

Study Sites (1)

Anxiety Disorders Clinic, New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 20531128 RESULT

Related Links

• New York State Psychiatric Institute Homepage
• Anxiety Disorders Association of America Homepage

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy; Escitalopram

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Franklin Schneier MD
• Organization: New York State Psychiatric Institute

fschneier@nyspi.columbia.edu

2125435368

Study Officials

• Franklin R. Schneier, M.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

• Kenneth D Belzer, Ph.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 19, 2017
• Results First Posted: May 9, 2012

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)