At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
Escitalopram +2 moredrug
Likely dose
Escitalopram 5 to 20 mg orally for 12 weeksAI-extracted
Key inclusion· 5
- ✓Confirmed diagnosis of major depressive disorder
- ✓HRSD(17) score of at least 14 indicating moderate depressive symptoms
- ✓Insomnia complaint present for at least 1 month
- ✓Fluent in English
Key exclusion· 14
- ✕Other psychiatric disorders including bipolar disorder, PTSD, OCD, or eating disorders
- ✕Psychotic symptoms
- ✕Serious, unstable, or terminal medical condition
- ✕Axis II personality disorder diagnosis: antisocial, schizotypal, or severe borderline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
In Brief
A Phase 2 clinical trial evaluating Escitalopram, CBTI, and 1 other intervention for Major Depressive Disorder and Insomnia. Completed, enrolled 30 participants across 1 site.
Detailed Summary
This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder, Insomnia
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2004
First PostedSep 2005
Primary CompletionAug 2007
TodayJul 2026
First PostedSep 8, 2005
Enrollment StartJun 1, 2004
Primary CompletionAug 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 20.8 years ago
Interventions
Escitalopramdrug
5 to 20 mg for 12 weeks
CBTIbehavioral
Cognitive Behavioral Treatment for Insomnia
CTRLbehavioral
Control Therapy consists of Pseudo-desensitization Therapy for Insomnia