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New treatment option for Major Depressive Disorder
Official title Mechanisms of Rumination Change in Adolescent Depression
ClinicalTrials.gov ID: NCT03859297
What this study is testing
- What it's testing
- 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.
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 17
You may be able to join if
- Previous diagnosis of Major Depressive Disorder (full or partial remission for at least two weeks) according to Diagnostic and Statistical Manual...
- 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
You likely can't join if
- Endorsement of suicidality with plan or intent (assessed via KSADSPL and Children's Depression Rating Scale (CDRS-R) clinical interviews. Current or...
- Lifetime history of conduct disorder, autism, any psychotic disorder (or episode unexplained by other known medical causes), or bipolar disorder...
- Current treatment with RF-CBT, Cognitive Behavioral Therapy (CBT), or variants thereof, or in the last 2 years. Likewise, detail oriented therapy...
- 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...
See the full eligibility 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...
- 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)
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.