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

NCT00462618 | Completed Phase 2

• 1 other identifier: H-19343
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Insomnia; Elderly; Affective disorders

Outcome Measures

Primary Outcomes (1)

• PTSQ

  12 weeks

Study Arms (1)

CBT

ACTIVE COMPARATOR

Drug: Quetiapine; Behavioral: Cogntive behavioral therapy

Interventions

Quetiapine DRUG

CBT

Cogntive behavioral therapy BEHAVIORAL

CBT

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael E. DeBakey VA Medical Center: lead

Study Sites (1)

Michael Debakey VAMC

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Mood Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rayan k Al Jurdi

  Michael Debakey VAMC, Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: April 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

US (1)