NCT06639477 Assessing Improvements in Mood and Sleep Trial
| NCT ID | NCT06639477 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 420 participants in total. It began in 2025-05-20 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multi-site randomized control trial involving people age 55+ years who have current depression symptoms plus another suicide risk indicator (either current suicidal ideation or a past history of attempt). Our goal is evaluate which of two different approaches works best to improve things like trouble sleeping, bad moods, and any suicidality. Participants will complete diagnostic interviews, self-report scales, and wear an actigraphy device for the 8 weeks starting at the baseline visit.
Eligibility Criteria
Inclusion Criteria: * Age 55 Years and older * Patient Health Questionnaire -9 score of 10 or higher * Past month Scale for Suicide Ideation score of 3 or higher OR any history of suicide attempt * PROMIS Sleep Disturbance or impairment scale t-scores of 55 or higher * Pharmacotherapy for depression meeting minimum adequate dose level as defined by FDA approval documents for at least 4 weeks. Exclusion Criteria: * Active suicide planning with intent or clinical judgement that suicide risk is too high for outpatient treatment OR being currently treated at an inpatient unit. * Bipolar disorder * Psychotic disorder * Borderline personality disorder. * Active Cognitive/Behavioral Therapy (e.g., CBT-I), current or upcoming esketamine (ketamine) treatment, or active phase of ECT/TMS treatment course. * Illness with life expectancy of less than 1 year or plans to leave the study area * Incapacity to consent/dementia diagnosis * Active substance use disorder of at least moderate severity * Active night-shift work * Any physical, mental, or neurological condition that would make participation in the study, including either treatment arm, unsafe or infeasible.
Contact & Investigator
Stephen F Smagula, Ph.D
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06639477 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06639477 currently recruiting?
Yes, NCT06639477 is actively recruiting participants. Contact the research team at alberts3@upmc.edu for enrollment information.
Where is the NCT06639477 trial being conducted?
This trial is being conducted at Los Angeles, United States, Augusta, United States, Pittsburgh, United States.
Who is sponsoring the NCT06639477 clinical trial?
NCT06639477 is sponsored by University of Pittsburgh. The principal investigator is Stephen F Smagula, Ph.D at University of Pittsburgh. The trial plans to enroll 420 participants.
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