Adolescent Depression Clinical Trial
Official title:
Omega-3 Fatty Acids in Adolescent Depression
Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of
adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of
omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1)
change in the total score of the Children's Depression Rating Scale-Revised (CDRS-R) at the
end of treatment (2) response rate on the Clinical Global Improvement scale (CGI) at the end
of 10-week treatment.
Hypothesis. Omega-3FA treatment in adolescents with MDD will result in a significant
reduction of CDRS-R total scores, and a significantly higher improvement rate on the CGI at
the end of treatment compared to placebo.
Title: Omega-3 Fatty Acids in Adolescents with Depression
NOTE: No individual will be advised to terminate ongoing treatment. If adolescents have been
in psychotherapy prior to their entry in the study, they will be allowed to continue with the
treatment. However, psychotherapy cannot be initiated at the time of entry into the study.
Aim: To provide preliminary clinical data about the efficacy of omega-3FA (derived from fish
oil) in the treatment of adolescent MDD. A NCCAM/NIH-funded study.
Summary: Informed consent will be obtained from parent/guardian and assent obtained from
participant. Interested participants will have a free diagnostic evaluation by study
psychiatrist to determine eligibility. Routine blood tests and a urine pregnancy test will be
obtained. Eligible participants will be randomized to receive either omega-3FA or matching
placebo (corn oil) for 10 weeks. Patients will be seen weekly throughout the trial. Dosage
will be titrated based on clinical response and side effects. At end of double-blind phase,
participants will be referred to a clinician who will be informed of subjects' treatment.
Depending on treatment received during double-blind phase, post-study treatment options will
include treatment with omega-3 fatty acids or an SSRI.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00399776 -
Bone Mineral Content and Bone Metabolism in Adolescents on Antipsychotic Therapy
|
N/A | |
| Completed |
NCT04603053 -
Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT
|
N/A | |
| Completed |
NCT01802437 -
An Adaptive Treatment Strategy for Adolescent Depression
|
Phase 1/Phase 2 | |
| Completed |
NCT06325605 -
Efficacy and Safety of Bifidobacterium Combined With High-frequency Transcranial Magnetic Stimulation in the Treatment of Adolescent Depression
|
N/A | |
| Completed |
NCT02017535 -
An Adaptive Treatment Strategy for Adolescent Depression-Continuation
|
Phase 1/Phase 2 | |
| Completed |
NCT03154008 -
Predictors of Response to Treatment for Depression
|
N/A | |
| Recruiting |
NCT04613453 -
Reducing Adolescent Suicide Risk: Safety, Efficacy, and Connectome Phenotypes of Intravenous Ketamine
|
Phase 2 | |
| Terminated |
NCT00284791 -
Lamotrigine in Treatment Resistant Depression in Adolescents
|
N/A | |
| Recruiting |
NCT01857518 -
Depression in Adolescents. A Cerebral Structural, Diffusion, and Functional Magnetic Resonance Imaging Study
|
N/A | |
| Recruiting |
NCT06072677 -
Adolescent Mood During Puberty and Testosterone
|
N/A | |
| Recruiting |
NCT01170520 -
Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents
|
Phase 1/Phase 2 |