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Omega-3 Fatty Acids for Treatment of Depression in Adolescents (PUFA)

Primary Purpose

Depression

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fish Oil
Cognitive Behavior Therapy
Placebo
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Adolescent Depression, Depression, Teenage Depression, Los Angeles

Eligibility Criteria

13 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. Diagnosed with major depressive disorder using the DSM-IV diagnostic criteria

Exclusion Criteria:

  1. Active suicidal ideation, with a current plan and/ or a recent suicide attempt
  2. Severe psychotic symptoms (presence of distressing or common hallucinations and/ or delusions)
  3. History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, or autism
  4. 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)
  5. 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
  6. Seizure or other neurological disorders
  7. Dermatological conditions
  8. Unstable cardiac, pulmonary, endocrine, or renal disorder
  9. Adolescents who are currently being effectively treated with antidepressants

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega-3 Fatty Acids

Placebo

Arm Description

Adolescents receive cognitive behavior therapy in combination with Omega-3 fatty acid supplements.

Adolescents receive cognitive behavior therapy in combination with placebo.

Outcomes

Primary Outcome Measures

Child Depression Inventory - CDI
Hamilton Depression Rating Scale

Secondary Outcome Measures

Full Information

First Posted
April 8, 2008
Last Updated
March 26, 2012
Sponsor
Cedars-Sinai Medical Center
Collaborators
National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT00658476
Brief Title
Omega-3 Fatty Acids for Treatment of Depression in Adolescents
Acronym
PUFA
Official Title
Treating Adolescent Depression With Fish Oils
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Adolescent Depression, Depression, Teenage Depression, Los Angeles

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 Fatty Acids
Arm Type
Experimental
Arm Description
Adolescents receive cognitive behavior therapy in combination with Omega-3 fatty acid supplements.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Adolescents receive cognitive behavior therapy in combination with placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish Oil
Intervention Description
Omega-3 fatty acid supplements.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Intervention Description
Adolescents receive cognitive behavior therapy.
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Child Depression Inventory - CDI
Time Frame
8 times for an average of 8 weeks
Title
Hamilton Depression Rating Scale
Time Frame
8 times for an average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayed Naqvi, M.D.
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

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Omega-3 Fatty Acids for Treatment of Depression in Adolescents

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