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Group Cognitive Behavioral Therapy (CBT I) Vs. Quetiapine for Residual Insomnia Impairing Recovery Among Elderly With Stable Major Affective Disorders

This study has been completed.
Information provided by (Responsible Party):
Rayan Al Jurdi, MD, Michael Debakey Veterans Affairs Medical Center Identifier:
First received: April 18, 2007
Last updated: April 22, 2013
Last verified: April 2013
The purpose of this pilot study is to assess feasibility and patient accessibility in order to design an adequately powered study to compare group cognitive behavioral therapy for insomnia (CBT-I) to quetiapine in non-demented patients aged 60 years or older with controlled bipolar disorder (I or II) or major depressive disorder who suffer from residual insomnia.

Condition Intervention Phase
Insomnia Drug: Quetiapine Behavioral: Cogntive behavioral therapy Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Rayan Al Jurdi, MD, Michael Debakey Veterans Affairs Medical Center:

Primary Outcome Measures:
  • PTSQ [ Time Frame: 12 weeks ]

Enrollment: 32
Study Start Date: April 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CBT Drug: Quetiapine Behavioral: Cogntive behavioral therapy


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age greater or equal to 60 years.
  2. Patients with history of major affective disorder, including Bipolar disorder type I or type II or major depressive disorder, as assessed by the Structured Clinical Interview for DSM-IV (SCID), currently in remission.
  3. Difficulty starting or initiating sleep four or more times/week for at least 3 months by history.
  4. Total Pittsburg Sleep Quality Index >5.

Exclusion Criteria:

  1. Patient in an acute mood episode as assessed by SCID
  2. Patients with sleep disruptive medical problems including: sleep apnea, restless leg syndrome, periodic limb movement, parasomnia, congestive heart failure, chronic pain and chronic obstructive pulmonary disease as assessed by medical history and medical record review.
  3. Patients with schizophrenia, primary anxiety disorder and active substance abuse as determined by SCID.
  4. Patients on or with history of failure or intolerance to respond to quetiapine.
  5. Patient with positive Alcohol Use Disorders Identification Test (AUDIT) with a total score above 8.
  6. Patients with dementia brain degenerative diseases, cognitive disorders and Mini Mental Status Examination (MMSE) score of less or equal to 24.
  7. Patients who are in an acute depressive, manic, hypomanic or mixed state as reflected by SCID
  8. Patients on concurrent sedating medications that would confound interpretation of the results. This is operationalized as follow: Sedating medications must be present and stable dosage for at least 14 days prior to enrollment in the study. If the medication is not prescribed as a primary sleep aid, it will be continued. Our rationale is that patients may need these medications and the initial sedating effect will have plateaued by 14 days. However, medications prescribed to assist insomnia will be discontinued as they are not effective for the subjects who otherwise meet inclusion ad exclusion criteria for the current study. Medications will be tapered as clinically indicated after the patients sing informed consent and prior to baseline assessment.
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Please refer to this study by its identifier: NCT00462618

United States, Texas
Michael Debakey VAMC
Houston, Texas, United States, 77030
Sponsors and Collaborators
Michael Debakey Veterans Affairs Medical Center
Principal Investigator: Rayan k Al Jurdi Michael Debakey VAMC, Baylor College of Medicine
  More Information

Responsible Party: Rayan Al Jurdi, MD, PI, Michael Debakey Veterans Affairs Medical Center Identifier: NCT00462618     History of Changes
Other Study ID Numbers: H-19343
Study First Received: April 18, 2007
Last Updated: April 22, 2013

Keywords provided by Rayan Al Jurdi, MD, Michael Debakey Veterans Affairs Medical Center:
Affective disorders

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Mood Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on September 21, 2017