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:
Michael Debakey Veterans Affairs Medical Center
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
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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:
- 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.
Contacts and Locations
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 Sleep Initiation and Maintenance Disorders Mental Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Quetiapine |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 18, 2013