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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.
Sponsor:
Information provided by (Responsible Party):
Rayan Al Jurdi, MD, Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00462618
First received: April 18, 2007
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Michael Debakey Veterans Affairs Medical Center:

Primary Outcome Measures:
  • PTSQ [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00462618

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

No publications provided

Responsible Party: Rayan Al Jurdi, MD, PI, Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00462618     History of Changes
Other Study ID Numbers: H-19343
Study First Received: April 18, 2007
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Michael Debakey Veterans Affairs Medical Center:
Insomnia
Elderly
Affective disorders

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014