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
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
Behavioral: Cognitive Behavioral-Therapy
Drug: escitalopram
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Therapy and Pharmacotherapy Augmentation for Generalized Anxiety Disorder: A Pilot Investigation

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: January 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Cognitive Behavioral-Therapy
    14 weekly sessions of individualized CBT
    Drug: escitalopram
    10-20 mg per day for 12 weeks
    Other Name: lexapro
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219349

Locations
United States, New York
Anxiety Disorders Clinic, New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Forest Laboratories
Investigators
Principal Investigator: Franklin R. Schneier, M.D. New York State Psychiatric Institute
Principal Investigator: Kenneth D Belzer, Ph.D. New York State Psychiatric Institute
  More Information

Additional Information:
Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00219349     History of Changes
Other Study ID Numbers: #4941
Study First Received: September 14, 2005
Results First Received: February 29, 2012
Last Updated: April 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
Anxiety Disorders
Anxiety Neuroses
Behavior Therapy, Cognitive
Escitalopram

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on April 17, 2014