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NCT05474846 · ClinicalTrials.gov registry record · Phase 2
Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer
A Phase 2 study of Depression and Cancer, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 188
- Enrollment target
- 1
- Study location
NCT05474846: Recruiting Phase 2 study of Depression and Cancer, sponsored by M.D. Anderson Cancer Center.
NCT05474846 is a Phase 2 study of Depression and Cancer that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 188 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05474846, a Phase 2 study of Depression and Cancer, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 188 participants
- Enrollment target
- 1
- Study location
Study Summary
To learn if Cognitive Behavior Therapy (called CBT), combined with either Bright Light Therapy (called BLT), methylphenidate, and/or melatonin, can help improve sleep and other related symptoms such as fatigue, anxiety, and depression in cancer patients. This is an investigational study. In this study, BLT, Methylphenidate and Melatonin will be compared to their placebos.
Primary Outcome
Pittsburgh Sleep Quality Index (PSQI) questionnaire score on a 4-point scale ranging from 0 (not during the 2 weeks) to 3 (3 or more times a week).
Conditions Studied
Interventions
- DRUG Melatonin
- DRUG Methylphenidate
- OTHER Placebo for Melatonin
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2022-11-21 |
| Est. Completion | 2027-02-28 |
| Phase | Phase 2 |
What NCT05474846 shows while recruiting
NCT05474846 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (76% lower).
The record links to 5 conditions, with Depression appearing as the primary indexed condition, and to 3 interventions - of which Melatonin is the first listed.
NCT05474846 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05474846 about?
NCT05474846 is a clinical study titled "Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer". To learn if Cognitive Behavior Therapy (called CBT), combined with either Bright Light Therapy (called BLT), methylphenidate, and/or melatonin, can help improve sleep and other related symptoms such as fatigue, anxiety, and depression in cancer patients. This is an investigational study. In this stu...
What is the current status of trial NCT05474846?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 188 participants. The study started on 2022-11-21. Estimated completion is 2027-02-28.
What conditions does trial NCT05474846 study?
This clinical trial studies the following conditions: Depression, Cancer, Anxiety, Sleep, Fatigue.
What interventions are being tested in trial NCT05474846?
The interventions under investigation include: Melatonin (DRUG), Methylphenidate (DRUG), Placebo for Melatonin (OTHER).
Who is sponsoring clinical trial NCT05474846?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05474846 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05474846's enrollment target sits among peer trials
188 218th of 679 higher than 462 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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