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
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.
Behavioral: Cogntive behavioral therapy
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Primary Outcome Measures:
- PTSQ [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2008 (Final data collection date for primary outcome measure)
Active Comparator: CBT
Behavioral: Cogntive behavioral therapy
|Ages Eligible for Study:
||60 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00462618
|Michael Debakey VAMC
|Houston, Texas, United States, 77030 |
Michael Debakey Veterans Affairs Medical Center
||Rayan k Al Jurdi
||Michael Debakey VAMC, Baylor College of Medicine
No publications provided
||Rayan Al Jurdi, MD, PI, Michael Debakey Veterans Affairs Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 18, 2007
||April 22, 2013
||United States: Institutional Review Board
United States: Federal Government
Keywords provided by Michael Debakey Veterans Affairs Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 20, 2014
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Nervous System Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents