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Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rachel Manber, Stanford University
ClinicalTrials.gov Identifier:
NCT00149825
First received: September 6, 2005
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.


Condition Intervention Phase
Major Depressive Disorder
Insomnia
Drug: Escitalopram
Behavioral: CBTI
Behavioral: CTRL
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Remission of Depression (%) [ Time Frame: After 12 weeks or at the last available time point ] [ Designated as safety issue: No ]

    Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.

    The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.

    The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains).



Secondary Outcome Measures:
  • Remission of Insomnia [ Time Frame: After 12 weeks or at the last available time point ] [ Designated as safety issue: No ]
    Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score < 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score < 8 indicates absence of insomnia.


Enrollment: 30
Study Start Date: June 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MED+CBTI
Escitalopram plus Cognitive Behavioral Therapy for Insomnia
Drug: Escitalopram
5 to 20 mg for 12 weeks
Other Names:
  • Escitalopram plus Cognitive behavioral Therapy
  • Escitalopram plus Pseudo-desensitization Therapy
Behavioral: CBTI
Cognitive Behavioral Treatment for Insomnia
Other Name: Cognitive Behavioral Treatment for Insomnia
Active Comparator: MED+CTRL
Escitalopram plus Pseudo-desensitization Therapy for Insomnia
Drug: Escitalopram
5 to 20 mg for 12 weeks
Other Names:
  • Escitalopram plus Cognitive behavioral Therapy
  • Escitalopram plus Pseudo-desensitization Therapy
Behavioral: CTRL
Control Therapy consists of Pseudo-desensitization Therapy for Insomnia
Other Name: Pseudo-desensitization Therapy for Insomnia

Detailed Description:

Difficulties falling and/or staying asleep are common in people who suffer from depression. Persistent insomnia can hinder response to treatment. In addition, individuals whose insomnia does not resolve with standard antidepressant therapy are at increased risk for recurrence of their depression. Between 60% and 84% of people who have major depressive disorder report symptoms of insomnia. This study will assess the efficacy of combining antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.

Participants in this double-blind study will be randomly assigned to receive either desensitization therapy or cognitive behavioral therapy to target insomnia. All participants will also receive escitalopram oxalate, an antidepressant medication. The study will last 12 weeks. The severity of participants' depression and insomnia will be assessed. Study visits will occur weekly for the first 6 weeks, bi-weekly for the last 6 weeks, and once 6 months post-intervention.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of major depressive disorder
  • HRSD(17) score of at least 14
  • Presence and complaint of insomnia for at least 1 month
  • Fluent in English
  • Use of an effective form of contraception throughout the study

Exclusion Criteria:

  • Other psychiatric disorders (e.g., bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, eating disorder)
  • Psychotic symptoms
  • Serious, unstable, or terminal medical condition
  • Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder
  • Substance abuse
  • Not willing to end other psychiatric treatment
  • Previous electroconvulsive therapy or vagus nerve stimulation treatment during the last year
  • Sleep apnea, restless leg, or periodic limb movement disorder (to be ruled out after first sleep study)
  • Other sleep disorders
  • Currently pregnant or breastfeeding
  • History of seizure disorder
  • Disease or condition that produces altered metabolism or hemodynamic responses
  • Liver or kidney dysfunction
  • Current use of any over the counter medications or herbs for mood or sleep benefits (e.g., melatonin, valerian, kava, hop extract, St. John's Wort, SAMe)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149825

Locations
United States, California
Stanford University
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Rachel Manber, PhD Stanford University Medical School, Department of Psychiatry and Behavioral Sciences
  More Information

Additional Information:
Publications:
Responsible Party: Rachel Manber, Dr. Rachel Manber, Stanford University
ClinicalTrials.gov Identifier: NCT00149825     History of Changes
Other Study ID Numbers: R21 MH066131, R21MH066131, DSIR 83-ATAS
Study First Received: September 6, 2005
Results First Received: July 30, 2009
Last Updated: May 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Stanford University:
Major Depressive Disorder
Insomnia
Sleep
Mental Health

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014