At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 138 enrolled
Drug / intervention
armodafinil +2 moredrug
Likely dose
armodafinil 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
In Brief
A Phase 2 clinical trial evaluating armodafinil, Placebo Comparator, and 1 other intervention for Insomnia and 2 related conditions. Completed, enrolled 138 participants across 2 sites.
Detailed Summary
This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female breast cancer patients who report sleep disturbances following completion of chemotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia, Fatigue, Breast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedMar 2010
Primary CompletionApr 2013
TodayJul 2026
First PostedMar 24, 2010
Enrollment StartFeb 1, 2008
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 16.3 years ago
Interventions
armodafinildrug
Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
Placebo Comparatordrug
Placebo for 47 days
CBT-Ibehavioral
Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)