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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00462618
Recruitment Status : Completed
First Posted : April 19, 2007
Last Update Posted : April 23, 2013
Information provided by (Responsible Party):
Rayan Al Jurdi, MD, Michael Debakey Veterans Affairs Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Insomnia Drug: Quetiapine Behavioral: Cogntive behavioral therapy Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: CBT Drug: Quetiapine
Behavioral: Cogntive behavioral therapy

Primary Outcome Measures :
  1. PTSQ [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Rayan Al Jurdi, MD, PI, Michael Debakey Veterans Affairs Medical Center Identifier: NCT00462618     History of Changes
Other Study ID Numbers: H-19343
First Posted: April 19, 2007    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 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