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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CBT

Group Type ACTIVE_COMPARATOR

Quetiapine

Intervention Type DRUG

Cogntive behavioral therapy

Intervention Type BEHAVIORAL

Interventions

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Quetiapine

Intervention Type DRUG

Cogntive behavioral therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No