Antidepressant Treatment Plus Cognitive Behavioral Therapy for Generalized Anxiety Disorder in Older Adults - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00601965

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Anxiety

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Hamilton Anxiety Rating Scale [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hamilton Depression Rating Scale [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
Quality of life and functioning (SF-36, FDI) [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
Neuropsychological functioning (RBANS, DKEFS Sorting Test, Stroop, LNS) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
HPA axis functioning (salivary cortisol) [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
Penn State Worry Questionnaire [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
Generalized Anxiety Disorder Symptom Scale [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

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	Drug: Escitalopram 20 mg daily oral escitalopram Behavioral: Cognitive behavioral therapy (CBT) 16 weekly 1-hour sessions
2: Active Comparator 12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram	Drug: Escitalopram 20 mg daily oral escitalopram
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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Principal (i.e., most severe or pressing problem) or coprincipal current diagnosis of generalized anxiety disorder
Pretreatment score of at least 17 on Hamilton Anxiety Rating Scale

Exclusion Criteria:

Principal diagnosis other than GAD
Clinically judged too psychiatrically unstable to participate in the study
Cognitive impairment or dementia
Alcohol or other substance use disorder within 6 months prior to study entry
Lifetime diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or bipolar disorder
Serious, unstable, or terminal medical condition that would compromise study participation or preclude the use of escitalopram, as determined by a review of medical records
Use of psychotropics that could not be safely tapered and discontinued for at least 2 weeks prior to study entry
Use of depot neuroleptics within 6 weeks prior to study entry
Unwillingness to terminate other forms of psychotherapy
Already received adequate trial of escitalopram or CBT

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601965

Contacts

Contact: Sara J. Parent, MA

619-725-3530

sparent@ucsd.edu

Locations

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, MD 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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Julie L. Wetherell, PhD

UCSD and VMRF/VASDHS

More Information

No publications provided

Responsible Party:	Washington University in St. Louis ( Eric J. Lenze, MD )
Study ID Numbers:	R34 MH080151, DATR A4-GPM
Study First Received:	January 15, 2008
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00601965 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses

Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Disease
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Anxiety Disorders
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009