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

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Quetiapine
Cogntive behavioral therapy
Sponsored by
Michael E. DeBakey VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Elderly, Affective disorders

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Michael Debakey VAMC

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

CBT

Arm Description

Outcomes

Primary Outcome Measures

PTSQ

Secondary Outcome Measures

Full Information

First Posted
April 18, 2007
Last Updated
April 22, 2013
Sponsor
Michael E. DeBakey VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00462618
Brief Title
Group Cognitive Behavioral Therapy (CBT I) Vs. Quetiapine for Residual Insomnia Impairing Recovery Among Elderly With Stable Major Affective Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michael E. DeBakey VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Elderly, Affective disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Type
Behavioral
Intervention Name(s)
Cogntive behavioral therapy
Primary Outcome Measure Information:
Title
PTSQ
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater or equal to 60 years. 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. Difficulty starting or initiating sleep four or more times/week for at least 3 months by history. Total Pittsburg Sleep Quality Index >5. Exclusion Criteria: Patient in an acute mood episode as assessed by SCID 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. Patients with schizophrenia, primary anxiety disorder and active substance abuse as determined by SCID. Patients on or with history of failure or intolerance to respond to quetiapine. Patient with positive Alcohol Use Disorders Identification Test (AUDIT) with a total score above 8. Patients with dementia brain degenerative diseases, cognitive disorders and Mini Mental Status Examination (MMSE) score of less or equal to 24. Patients who are in an acute depressive, manic, hypomanic or mixed state as reflected by SCID 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rayan k Al Jurdi
Organizational Affiliation
Michael Debakey VAMC, Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael Debakey VAMC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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