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

April 18, 2007
April 22, 2013
April 2007
March 2008   (final data collection date for primary outcome measure)
PTSQ [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00462618 on ClinicalTrials.gov Archive Site
Not Provided
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Group Cognitive Behavioral Therapy (CBT I) Vs. Quetiapine for Residual Insomnia Impairing Recovery Among Elderly With Stable Major Affective Disorders
Not Provided

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Insomnia
  • Drug: Quetiapine
  • Behavioral: Cogntive behavioral therapy
Active Comparator: CBT
Interventions:
  • Drug: Quetiapine
  • Behavioral: Cogntive behavioral therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00462618
H-19343
No
Rayan Al Jurdi, MD, Michael Debakey Veterans Affairs Medical Center
Michael Debakey Veterans Affairs Medical Center
Not Provided
Principal Investigator: Rayan k Al Jurdi Michael Debakey VAMC, Baylor College of Medicine
Michael Debakey Veterans Affairs Medical Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP