Omega-3 Fatty Acids for Treatment of Depression in Adolescents (PUFA)
This study has been completed.
Sponsor:
Cedars-Sinai Medical Center
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00658476
First received: April 8, 2008
Last updated: March 26, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Adolescence is the highest risk period for depression onset. More than 1.3 million youths suffer from major depression annually in the United States, and there is evidence for an increasing trend. Because many adolescents have their first depressive episode in adolescence and adolescent depression often leads to recurrent mood disorders in adults, effective treatment during early illness can minimize the negative consequences of initial and repeated episodes. Although some antidepressants (particularly Selective serotonin reuptake inhibitors (SSRIs)) are effective treatments for juvenile depression, recent warnings about suicide and the use of SSRls highlight the need for new and safe treatment for juvenile depression. Data in adults suggest that supplementation with polyunsaturated fatty acids (PUFA) might be useful for the treatment of depression. The purpose of this study is to investigate the safety and efficacy of PUFA for the treatment of adolescent depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Dietary Supplement: Fish Oil Behavioral: Cognitive Behavior Therapy Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treating Adolescent Depression With Fish Oils |
Resource links provided by NLM:
Further study details as provided by Cedars-Sinai Medical Center:
Primary Outcome Measures:
- Child Depression Inventory - CDI [ Time Frame: 8 times for an average of 8 weeks ] [ Designated as safety issue: No ]
- Hamilton Depression Rating Scale [ Time Frame: 8 times for an average of 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 4 |
| Study Start Date: | November 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Omega-3 Fatty Acids
Adolescents receive cognitive behavior therapy in combination with Omega-3 fatty acid supplements.
|
Dietary Supplement: Fish Oil
Omega-3 fatty acid supplements.
Behavioral: Cognitive Behavior Therapy
Adolescents receive cognitive behavior therapy.
|
|
Placebo Comparator: Placebo
Adolescents receive cognitive behavior therapy in combination with placebo.
|
Behavioral: Cognitive Behavior Therapy
Adolescents receive cognitive behavior therapy.
Other: Placebo
|
Eligibility| Ages Eligible for Study: | 13 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adolescents between the ages of 13 and 21 currently under standard of care treatment at the Child Division of the Department of Psychiatry at CSMC
- Diagnosed with major depressive disorder using the DSM-IV diagnostic criteria
Exclusion Criteria:
- Active suicidal ideation, with a current plan and/ or a recent suicide attempt
- Severe psychotic symptoms (presence of distressing or common hallucinations and/ or delusions)
- History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, or autism
- Potential subjects using psychotropic medication(s), alcohol, and/ or drugs within 2 weeks prior to entry into the study (8 weeks for fluoxetine and MAOIs - monoamine oxidase inhibitors)
- Pregnant or lactating females, or those who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy) and become pregnant
- Seizure or other neurological disorders
- Dermatological conditions
- Unstable cardiac, pulmonary, endocrine, or renal disorder
- Adolescents who are currently being effectively treated with antidepressants
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658476
Locations
| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
Sponsors and Collaborators
Cedars-Sinai Medical Center
National Alliance for Research on Schizophrenia and Depression
Investigators
| Principal Investigator: | Sayed Naqvi, M.D. | Cedars-Sinai Medical Center |
More Information
No publications provided
| Responsible Party: | Dr. Sayed Naqvi, M.D., Cedars-Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT00658476 History of Changes |
| Other Study ID Numbers: | 9407 |
| Study First Received: | April 8, 2008 |
| Last Updated: | March 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cedars-Sinai Medical Center:
|
Adolescent Depression Depression Teenage Depression Los Angeles |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 17, 2013