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Official Study Title: CBT Augmentation and Maintenance of SSRI treatment for Geriatric GAD
Sponsor: National Institutes of Mental Health, Forest Laboratories
Clinicaltrials.gov ID: NCT00601965
Study ID: 06-1007

Summary

Almost one in ten older Americans experiences worry or anxiety that interferes with day-to-day activities or getting to sleep. These problems are more common than depression , Alzheimer’s disease, or other dementias in older adults. Generalized anxiety disorder (GAD) is characterized by hard to control worry about health, family, finances, or minor matters, along with other symptoms like feeling restless, tense, irritable, or trouble sleeping or concentrating. Current treatments for GAD include medication and psychotherapy. This study examines whether adding a type of psychotherapy called cognitive  CognitiveRelated to mental activities having to do with perception, memory, judgment, and reasoning. behavioral therapy  TherapyAnother word for “treatment”. (CBT) to the antidepressant medication escitalopram (Lexapro) can help older adults with GAD get better and stay well. Escitalopram is FDA-approved for treating GAD. People with Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD) may be eligible for this study along with their caregivers and other people who do not have PD.

The study has three phases, lasting up to 13 months. In the first phase, participants will take escitalopram for 12 weeks. In the second phase, all participants will continue taking escitalopram for another 16 weeks. In addition, half of the participants will be randomly assigned to receive 16 weekly sessions of CBT. CBT involves learning relaxation techniques and other skills to manage anxiety. In the third phase, participants will be randomly assigned to receive either continued escitalopram or a placebo  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. for an additional 28 weeks. This phase of the study is double-blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. meaning that neither the participant nor the research team will know whether the participant is taking escitalopram or placebo.

Throughout the study, participants will be asked to answer questions about symptoms of worry or anxiety and perform tests of memory and thinking. Investigators will also take blood and saliva samples to evaluate the effects of treatment on stress hormones that can lead to health problems and dementia.  DementiaA decline in higher-level brain functions, such as memory, reasoning and personality.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Non-movement Symptoms

Anxiety

Time Commitment

• More than six months
• On average, once every two weeks.

Eligibility

• Minimum Age: 60
• Gender(s) Accepted: Either
• Study is enrolling non-PD participants

Inclusion Criteria

For PD and non-PD participants:

• Generalized anxiety disorder
• At least 60 years old

Exclusion Criteria

For PD and non-PD participants: 

• Dementia or cognitive impairment
• Alcohol or other substance abuse problems
• Serious mental illness such as schizophrenia or bipolar disorder
• Unwillingness to stop other forms of treatment for anxiety (such as other medications) while participating in the study

Enrollment

Expected Enrollment: 60 (US)
Date Enrollment Began: Oct 2007
Date Enrollment Ends: Jul 2010
Last Updated Date: Sep 11 2009
Trial Post Date: Sep 11 2009
Website: http://www.clinicaltrials.gov/ct2/show/NCT00601965?term=wetherell&rank=2

Primary Contacts and Locations

California

• Sara Parent
  sparent@ucsd.edu
  Phone: (619) 725-3530
  UCSD Outpatient Psychiatric Clinic
  140 Arbor Drive
  San Diego, CA 92103
  USA
  
• Sara Parent
  sparent@ucsd.edu
  Phone: (619) 725-3530
  Veterans Medical Research Foundation
  3350 La Jolla Village Drive (151A), Building 13
  San Diego, CA 92161
  USA