NCT03859297 Mechanisms of Rumination Change in Adolescent Depression
| NCT ID | NCT03859297 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 183 participants |
| Start Date | 2019-05-01 |
| Primary Completion | 2028-04-14 |
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 183 participants in total. It began in 2019-05-01 with a primary completion date of 2028-04-14.
⚠ 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 study will evaluate whether a newer treatment, rumination-focused cognitive behavioral treatment, which includes mindfulness and can be used to reduce ruminative habits, change ways in which key brain regions interact with each other (e.g.., often called connectivity), and whether these changes in habits and brain connectivity can reduce the risk for recurrence of depression in the next two years.
Eligibility Criteria
Inclusion Criteria: * Previous diagnosis of Major Depressive Disorder (full or partial remission for at least two weeks) according to Diagnostic and Statistical Manual (DSM-V) criteria confirmed by the Kiddie Schedule for affective disorders (KSADSPL). Partial remission is defined as not meeting full DSM-V criteria for MDD. * RRS score above the age and sex specific mean, T \> 50). * 14-17 years of age at enrollment (accounting for 2 year follow-up), * Postpubertal (Petersen Pubertal Developmental Scale) * Youth assent and parent consent * Intellectual Quotient (IQ) \> 75, determined by Wechsler Abbreviated Scale of Intelligence (WASI) Exclusion Criteria: * Endorsement of suicidality with plan or intent (assessed via KSADSPL and Children's Depression Rating Scale (CDRS-R) clinical interviews. Current or past (within previous three months) plan or intent is exclusionary. * Lifetime history of conduct disorder, autism, any psychotic disorder (or episode unexplained by other known medical causes), or bipolar disorder. Eating disorder or alcohol/substance abuse within the previous 6 months. (Lifetime history of an anxiety disorder, disruptive mood dysregulation disorder or oppositional defiant disorder, Attention Deficit Hyperactivity Disorder (ADHD) will not be exclusionary). * Current treatment with RF-CBT, Cognitive Behavioral Therapy (CBT), or variants thereof, or in the last 2 years. Likewise, detail oriented therapy beyond supportive therapy (e.g., homework, cognitive restructuring), in same time window (ability to recall elements of structured therapies with CBT focus). * Metal braces or retainers, tattoos with metal, or clothing with metal fibers. * Claustrophobia * Current pregnancy - Parents will be asked this information at the phone screen. At the clinic eligibility visit, female participants will be asked about sexual activity in a private room separate from their parents using the pregnancy script/screen that the investigators have created. This script details that if a female is ineligible due to pregnancy or inadequate birth control, this information will not be disclosed to her parent(s). Participants who are sexually active will be asked about birth control method. Abstinence will be considered an approved form of contraception. * Psychotropic medication outside of antidepressants such as mood stabilizers and antipsychotics will be exclusionary. Participants may have a history of current, stable antidepressant medication use, with no changes in dose for the past four weeks, no change in specific medication for six weeks.
Contact & Investigator
Scott Langenecker, Ph.D.
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT03859297 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 17 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03859297 currently recruiting?
Yes, NCT03859297 is actively recruiting participants. Contact the research team at scott.langenecker@osumc.edu for enrollment information.
Where is the NCT03859297 trial being conducted?
This trial is being conducted at Columbus, United States, Columbus, United States, Salt Lake City, United States.
Who is sponsoring the NCT03859297 clinical trial?
NCT03859297 is sponsored by Ohio State University. The principal investigator is Scott Langenecker, Ph.D. at Ohio State University. The trial plans to enroll 183 participants.