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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00601965 |
This study will assess whether adding cognitive behavioral therapy to the antidepressant escitalopram is effective in reducing anxiety in older adults with generalized anxiety disorder.
Condition | Intervention |
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Generalized Anxiety Disorder |
Drug: Escitalopram Drug: Placebo Behavioral: Cognitive behavioral therapy (CBT) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | CBT Augmentation of SSRI Treatment for Geriatric GAD |
Estimated Enrollment: | 80 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram
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Drug: Escitalopram
20 mg daily oral escitalopram
Behavioral: Cognitive behavioral therapy (CBT)
16 weekly 1-hour sessions
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2: Active Comparator
12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram
|
Drug: Escitalopram
20 mg daily oral escitalopram
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3: Placebo Comparator
12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo
|
Drug: Escitalopram
20 mg daily oral escitalopram
Drug: Placebo
Placebo pill of daily oral escitalopram
Behavioral: Cognitive behavioral therapy (CBT)
16 weekly 1-hour sessions
|
4: Placebo Comparator
12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo
|
Drug: Escitalopram
20 mg daily oral escitalopram
Drug: Placebo
Placebo pill of daily oral escitalopram
|
Generalized anxiety disorder (GAD) affects nearly 6.8 million adults in the United States. GAD is diagnosed when a person spends at least 6 months excessively worrying over everyday problems to the point that carrying out normal life becomes difficult. People with GAD face each day with intense anxiety and tension and are unable to alleviate their worries. Physical symptoms of GAD include muscle aches, nausea, sweating, exhaustion, irritability, frequent urination, shaking, and hot flashes. People with GAD often experience other anxiety disorders, depression, or substance abuse, all of which can worsen symptoms of GAD. This makes early and appropriate treatment for GAD important. Current treatments for GAD include medication and/or types of psychotherapy. This study will assess whether adding cognitive behavioral therapy (CBT) to the antidepressant escitalopram is effective in reducing anxiety in older adults with GAD.
Participation in this double-blind study will last up to 13 months. Participants will be asked to stop any current treatments for anxiety or depression for the duration of the study. Participants will begin taking one pill of the medication escitalopram daily for 12 weeks. Dosage will be increased to two pills each day if symptoms do not improve within 4 weeks. After 12 weeks, all participants will continue taking escitalopram for an additional 16 weeks. In addition, some participants will be randomly assigned to receive 16 weekly sessions of CBT, lasting 1 hour each. CBT sessions will involve learning relaxation techniques and other skills to manage anxiety and completing 30-minute at-home practice assignments each day. A family member will accompany participants to the first four CBT sessions. All participants will be asked to provide information for a close contact, who will be interviewed at baseline, Month 3, and Month 7 about how the participant's anxiety is affecting his or her relationships.
After the 16-week period, participants will again be randomly assigned to receive either continued escitalopram or a placebo for an additional 28 weeks. Participants assigned to the placebo will be gradually tapered off escitalopram over a 6-week period. Participants who were receiving CBT will receive three more sessions. Throughout the study, participants will be asked to complete various assessments, including questionnaires, memory and thinking tests, and attention evaluations. Blood samples will be taken at Weeks 2 and 8, and saliva samples will be taken at baseline and Weeks 12, 28, and 56.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sara J. Parent, MA | 619-725-3530 | sparent@ucsd.edu |
United States, California | |
UCSD Outpatient Psychiatric Services | Recruiting |
San Diego, California, United States, 92103 | |
Sub-Investigator: Sidney Zisook, MD | |
United States, Missouri | |
Washington University | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Eric J. Lenze, M.D. 314-362-1671 lenzee@psychiatry.wustl.edu | |
Principal Investigator: Eric J. Lenze, MD | |
United States, Pennsylvania | |
University of Pittsburgh | Active, not recruiting |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Julie L. Wetherell, PhD | UCSD and VMRF/VASDHS |
Responsible Party: | University of Pittsburgh ( Meryl Butters, PhD ) |
Study ID Numbers: | R34 MH080151, DATR A4-GPM |
Study First Received: | January 15, 2008 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00601965 |
Health Authority: | United States: Federal Government |
Anxiety Disorders Mental Disorders Dexetimide Citalopram Serotonin |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |