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 (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 ]
The Hamilton Anxiety Rating Scale will be used to test hypotheses number 1 and 2.
Penn State Worry Questionnaire [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
The Penn State Worry Questionnaire will be used to test hypothesis number 3.

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 ]
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:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram	Drug: Escitalopram 20 mg daily oral escitalopram Other Name: Lexapro Behavioral: Cognitive behavioral therapy (CBT) 16 weekly 1-hour sessions
Active Comparator: 2 12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram	Drug: Escitalopram 20 mg daily oral escitalopram Other Name: Lexapro
Placebo Comparator: 3 12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo	Drug: Escitalopram 20 mg daily oral escitalopram Other Name: Lexapro Drug: Placebo Placebo pill of daily oral escitalopram Behavioral: Cognitive behavioral therapy (CBT) 16 weekly 1-hour sessions
Placebo Comparator: 4 12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo	Drug: Escitalopram 20 mg daily oral escitalopram Other Name: Lexapro 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 co-principal 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

Locations

United States, California
UCSD Outpatient Psychiatric Services
San Diego, California, United States, 92103
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
University of Pittsburgh
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:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00601965 History of Changes
Other Study ID Numbers:	R34 MH080151, DATR A4-GPM
Study First Received:	January 15, 2008
Last Updated:	August 29, 2011
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
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
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 09, 2012