Major Depressive Disorder Clinical Trial
Official title:
Evaluation of Omega-3 Fatty Acids as a Treatment-adjunct in Adolescent Patients With Major Depressive Disorder Exhibiting Partial Response to SSRI Medications: An Open-label Neuroimaging Trial
The primary objective of the study was to determine the effects of 10-week adjunctive
supplementation with 2 doses of LCn-3 fatty acids (fish oil) on cortical functional activity
and biochemistry in adolescents with MDD.
The primary prediction was that LCn-3 fatty acid supplementation would dose-dependently
increase prefrontal cortical functional activation during sustained attention and increase
regional biochemical indices of cortical metabolism and integrity concentrations in
association with reductions in depressive symptoms.
This study is a 10-week open-label EPA+DHA treatment trial in adolescent (aged 12-18 years)
patients with major depressive disorder exhibiting partial response to SSRI medications.
After a screening visit, patients were randomized (stratified by gender) to open-label fish
oil supplements at a fixed dose of either 2.4 g/day or 15 g/day (2 tablespoons/day) for 10
weeks.
A physical examination, a complete blood count (CBC), and thyroid stimulating hormone (TSH)
levels were determined at baseline and Week 10, and vital signs (pulse, blood pressure,
weight, height, body mass index, temperature) were obtained at each visit. At each visit,
safety and tolerability were assessed using a structured side effect interview, the Side
Effects Form for Children and Adolescents.
At baseline and all weekly visits, depression symptom severity was determined with the
Children's Depression Rating Scale-Revised (CDRS-R), a 17-item observer-rated questionnaire,
and remission was defined as a CDRS-R score of ≥28. If a patient's depressive symptoms
worsened over the course of the trial (defined as 30% worsening relative to baseline on two
consecutive visits using CDRS-R scores), they were withdrawn from the study. In view of the
potential risk for developing hypomanic symptoms following LCn-3 fatty acid supplementation,
manic symptom severity was monitored over the course of the trial with the Young Mania
Rating Scale (YMRS), an 11-item observer-rated questionnaire.
fMRI scans were performed at baseline and at 10 weeks.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
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 | |
Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A |