Major Depressive Disorder Clinical Trial
Official title:
Early Intervention for Youth at Risk for Bipolar Disorder
Verified date | September 2021 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Children or teens with mood swings or depression who have a parent with bipolar disorder are at high risk for developing bipolar disorder themselves. This study will test a family-based therapy aimed at preventing or reducing the early symptoms of bipolar disorder in high-risk children (ages 9-17). In a randomized trial, the investigators will compare two kinds of family-based treatment (one more and one less intensive) on the course of early mood symptoms and social functioning among high-risk children followed for up to 4 years. The investigators will examine the effects of family treatment on measures of neural activation using functional magnetic resonance imaging.
Status | Completed |
Enrollment | 150 |
Est. completion date | September 15, 2020 |
Est. primary completion date | September 15, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years to 17 Years |
Eligibility | Inclusion Criteria: - For a child to be eligible: - At least one biological parent or stepparent with whom the child or adolescent lives must be willing to participate in family treatment - At least one biological parent has a verifiable diagnosis of bipolar disorder I or II - The child must have a DSM-IV diagnosis of bipolar disorder not otherwise specified or major depressive disorder (MDD) - If the main diagnosis is MDD, the depressive episode must have occurred within the past 2 years - The child must have evidence of current significant affective symptoms, as determined by a score greater than 11 on the Young Mania Rating Scale within the last week or a score greater than 29 on the Child Depression Rating Scale-Revised within the last 2 weeks - The family must speak English, although English need not be their first language Exclusion Criteria: - Fully diagnosable bipolar disorder I or II - Diagnosis of autism or pervasive developmental disorder - Evidence of mental retardation, as defined by an intelligence quotient (IQ) less than 70 - Presence of comorbid neurologic diseases such as seizure disorder - Substance or alcohol abuse or dependence disorders in the 4 months prior to study recruitment - Evidence of a life-threatening eating disorder or other medical disorder that requires emergency medical treatment - Currently enrolled in regular family therapy - Evidence of current sexual or physical abuse or domestic abuse between the adult partners |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado, Boulder | Boulder | Colorado |
United States | UCLA Child and Adolescent Mood Disorders Program, UCLA School of Medicine | Los Angeles | California |
United States | Stanford University School of Medicine, Lucile Packard Children's Hospital | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | Stanford University, University of Colorado, Boulder |
United States,
Miklowitz DJ, Chang KD, Taylor DO, George EL, Singh MK, Schneck CD, Dickinson LM, Howe ME, Garber J. Early psychosocial intervention for youth at risk for bipolar I or II disorder: a one-year treatment development trial. Bipolar Disord. 2011 Feb;13(1):67-75. doi: 10.1111/j.1399-5618.2011.00890.x. — View Citation
Miklowitz DJ, Chang KD. Prevention of bipolar disorder in at-risk children: theoretical assumptions and empirical foundations. Dev Psychopathol. 2008 Summer;20(3):881-97. doi: 10.1017/S0954579408000424. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in symptom severity | Changes in symptoms of at-risk children, as defined by depression and (hypo)mania scores and psychiatric status on the Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE, the Child Depression Rating Scale, and the Young Mania Rating Scale | Measured at baseline, every 4 months in year 1, and every 6 months in years 2-4 | |
Secondary | Delaying onset of a first (hypo)manic or mixed episode | We will evaluate through survival analyses whether family-focused treatment, due to its ameliorative effects on acute symptoms, is superior to enhanced care in delaying onset of a first (hypo)manic or mixed episode during the 2-4 year follow-up. | 2-4 years | |
Secondary | Psychosocial functioning | Youths in family-focused treatment will show greater improvement from pretreatment to end of a 2-4 year follow-up in psychosocial functioning compared to youth in Enhanced Care. | Measured at baseline, every 4 months in year 1 and every 6 months in years 2-4 | |
Secondary | Mental health service use | Youth in family-focused treatment will require fewer mental health services from pretreatment to end of a 2-4 year follow-up than youth in enhanced care | Measured at baseline, every 4 months in year 1 and every 6 months in years 2-4 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05537558 -
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
|
||
Terminated |
NCT02192099 -
Open Label Extension for GLYX13-C-202, NCT01684163
|
Phase 2 | |
Completed |
NCT03142919 -
Lipopolysaccharide (LPS) Challenge in Depression
|
Phase 2 | |
Recruiting |
NCT05547035 -
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
|
N/A | |
Terminated |
NCT02940769 -
Neurobiological Effects of Light on MDD
|
N/A | |
Recruiting |
NCT05892744 -
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
|
Phase 4 | |
Recruiting |
NCT05537584 -
SMART Trial to Predict Anhedonia Response to Antidepressant Treatment
|
Phase 4 | |
Active, not recruiting |
NCT05061706 -
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT04479852 -
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
|
Phase 2 | |
Recruiting |
NCT04032301 -
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
|
Phase 1 | |
Recruiting |
NCT05527951 -
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
|
N/A | |
Completed |
NCT03511599 -
Cycloserine rTMS Plasticity Augmentation in Depression
|
Phase 1 | |
Recruiting |
NCT04392947 -
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
|
N/A | |
Recruiting |
NCT05895747 -
5-HTP and Creatine for Depression R33 Phase
|
Phase 2 | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Recruiting |
NCT05813093 -
Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
|
N/A | |
Recruiting |
NCT05135897 -
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
|
||
Enrolling by invitation |
NCT04509102 -
Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder
|
Early Phase 1 | |
Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A | |
Recruiting |
NCT06026917 -
Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
|
Phase 4 |