Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Antidepressant Treatment Plus Cognitive Behavioral Therapy for Generalized Anxiety Disorder in Older Adults

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00601965
First received: January 15, 2008
Last updated: July 14, 2016
Last verified: July 2016
  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:


Further study details as provided by Veterans Medical Research Foundation:

Primary Outcome Measures:
  • Hamilton Anxiety Rating Scale [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
    The Hamilton Anxiety Rating Scale is a clinician-rated measure of cognitive and somatic anxiety symptoms. It consists of 14 items, each of which is scored on a 0-4 scale, summed for a total score ranging from 0 to 56. Inclusion criteria for this study included a Hamilton score >= 17. The Hamilton, administered by blind raters, will be used to test hypotheses number 1 and 2. The outcome of interest is the number of participants who relapse, defined as having a Hamilton increase of >=5, for a total Hamilton >=14, relative to the end of the continuation phase (week 28), for a duration of at least 2 weeks, plus both clinician's and participant's judgment that the participant is experiencing a recurrence of anxiety symptoms. HAMA scores range from 0 (no anxiety) to 56 (high anxiety).

  • Penn State Worry Questionnaire [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
    The Penn State Worry Questionnaire is a 16-item measure of pathological worry. Scores range from 16-80, with higher scores indicating higher levels of worry.


Enrollment: 73
Study Start Date: October 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT/Escitalopram
12 weeks open-label escitalopram (10-20mg/day as tolerated), followed by 16 weeks individual cognitive behavioral therapy plus continuation escitalopram at same dose as end of first 12 weeks, followed by 28 weeks maintenance escitalopram at same dose as at end of first 12 weeks. Up to 3 booster sessions of CBT allowed during the 28 week maintenance phase. CBT consists of 16 sessions of relaxation training, cognitive restructuring, and problem-solving skills training.
Drug: Escitalopram
20 mg daily oral escitalopram
Other Name: Lexapro
Behavioral: Cognitive behavioral therapy (CBT)
16 weekly 1-hour sessions
Other Name: CBT
Active Comparator: No CBT/escitalopram
12 weeks open-label escitalopram (10-20 mg/day as tolerated), followed by 16 weeks continuation escitalopram at same dose as at end of first 12 weeks, followed by 28 weeks maintenance escitalopram at same dose as at end of first 12 weeks.
Drug: Escitalopram
20 mg daily oral escitalopram
Other Name: Lexapro
Placebo Comparator: CBT/placebo
12 weeks open-label escitalopram (10-20mg/day as tolerated), followed by 16 weeks individual cognitive behavioral therapy plus continuation escitalopram at same dose as end of first 12 weeks, followed by 28 weeks of pill placebo. 28 weeks of pill placebo includes a taper period of a duration dependent on the initial dose of escitalopram, but in all cases taper to placebo is complete after 8 weeks. Up to 3 booster sessions of CBT allowed during the 28 week maintenance phase. CBT consists of 16 sessions of relaxation training, cognitive restructuring, and problem-solving skills training.
Drug: Placebo
Placebo pill of daily oral escitalopram
Other Name: Sugar pill
Behavioral: Cognitive behavioral therapy (CBT)
16 weekly 1-hour sessions
Other Name: CBT
Placebo Comparator: No CBT/placebo

12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo

12 weeks open-label escitalopram (10-20 mg/day as tolerated), followed by 16 weeks continuation escitalopram at same dose as at end of first 12 weeks, followed by 28 weeks of pill placebo. 28 weeks of pill placebo includes a taper period of a duration dependent on the initial dose of escitalopram, but in all cases taper to placebo is complete after 8 weeks.

Drug: Placebo
Placebo pill of daily oral escitalopram
Other Name: Sugar pill

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Veterans Medical Research Foundation
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Julie L. Wetherell, PhD UCSD and VMRF/VASDHS
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Veterans Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00601965     History of Changes
Other Study ID Numbers: R34MH080151 
Study First Received: January 15, 2008
Results First Received: September 3, 2014
Last Updated: July 14, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Citalopram
Dexetimide
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
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on December 06, 2016