Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01091974 · ClinicalTrials.gov registry record · Phase 2
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
A Phase 2 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
NCT01091974 is a Phase 2 study that has completed, run by University of Rochester. The registered enrollment target is 138 participants.
The verdict
NCT01091974, a Phase 2 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo Comparator
- BEHAVIORAL CBT-I
- DRUG armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2008-02 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01091974
The ClinicalTrials.gov registry entry for NCT01091974 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo Comparator is the first listed.
NCT01091974 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01091974 about?
NCT01091974 is a clinical study titled "Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy". 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.
What is the current status of trial NCT01091974?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2008-02. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01091974?
The interventions under investigation include: Placebo Comparator (DRUG), CBT-I (BEHAVIORAL), armodafinil (DRUG).
Who is sponsoring clinical trial NCT01091974?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.