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Trial record 8 of 534 for:    ESCITALOPRAM AND Disorders

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00219349
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : May 9, 2012
Last Update Posted : December 19, 2017
Forest Laboratories
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Behavioral: Cognitive Behavioral Therapy Drug: escitalopram Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Therapy and Pharmacotherapy Augmentation for Generalized Anxiety Disorder: A Pilot Investigation
Study Start Date : January 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Escitalopram
12 weeks of open label escitalopram, 10-20 mg/day (after 14 weeks of cognitive behavioral therapy
Behavioral: Cognitive Behavioral Therapy
14 weekly sessions of individualized CBT

Drug: escitalopram
10-20 mg per day for 12 weeks
Other Name: lexapro

Primary Outcome Measures :
  1. Change in Hamilton Anxiety Rating Scale Score [ Time Frame: week 14 to week 26 ]
    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.

  2. Change in Clinical Global Impressions-Severity Index [ Time Frame: week 14 to week 26 ]
    7 point scale of overall severity of psychopathology from 1 mildest to 7 most severe.

  3. Change in Generalized Anxiety Disorder Severity Scale [ Time Frame: week 14 to week 26 ]
    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.

  4. Change in Penn State Worry Questionnaire [ Time Frame: week 14 to week 26 ]
    total score (of 16 items) ranging from 16 (least worry) to 80 (most worry)

  5. Change in State-Trait Anxiety Inventory, State Subscale [ Time Frame: week 14 to week 26 ]
    only the total score of the state anxiey subscale was used. Range is from 20 (mildest) to 80 (most severe)

Secondary Outcome Measures :
  1. Clinical Global Impressions-Improvement Index [ Time Frame: week 26 ]
    This is a single item rating overall symptomatic improvement. Range is 0 (very much worse) to 7 (very much improved)

  2. Change in Hamilton Rating Scale for Depression [ Time Frame: week 14 to week 26 ]
    24 item version of this standard depression scale, total score ranges from 0 (not depressed) to 58 (most severe)

  3. Change in Beck Depression Inventory-II [ Time Frame: week 14 to week 26 ]
    total score ranges from 0 (not depressed) to 63 (most severe)

Information from the National Library of Medicine

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

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00219349

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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
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Principal Investigator: Franklin R. Schneier, M.D. New York State Psychiatric Institute
Principal Investigator: Kenneth D Belzer, Ph.D. New York State Psychiatric Institute

Additional Information:
Publications of Results:
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Responsible Party: New York State Psychiatric Institute Identifier: NCT00219349     History of Changes
Other Study ID Numbers: #4941
First Posted: September 22, 2005    Key Record Dates
Results First Posted: May 9, 2012
Last Update Posted: December 19, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Pathologic Processes
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
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents