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

Insomnia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462618
• Other study ID #: H-19343
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 18, 2007
• Last updated: April 22, 2013
• Start date: April 2007
• Est. completion date: March 2008

Study information

• Verified date: April 2013
• Source: Michael Debakey Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Mood Disorders
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Quetiapine

Behavioral:
• Cogntive behavioral therapy

Locations

Country	Name	City	State
United States	Michael Debakey VAMC	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Michael Debakey Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSQ		12 weeks