NCT00658476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_3 depression

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

March 27, 2012

Status Verified

March 1, 2012

Enrollment Period

2.4 years

First QC Date

April 8, 2008

Last Update Submit

March 26, 2012

Conditions

Depression

Keywords

Adolescent DepressionDepressionTeenage DepressionLos Angeles

Outcome Measures

Primary Outcomes (2)

  • Child Depression Inventory - CDI

    8 times for an average of 8 weeks

  • Hamilton Depression Rating Scale

    8 times for an average of 8 weeks

Study Arms (2)

Omega-3 Fatty Acids

EXPERIMENTAL

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

Dietary Supplement: Fish OilBehavioral: Cognitive Behavior Therapy

Placebo

PLACEBO COMPARATOR

Adolescents receive cognitive behavior therapy in combination with placebo.

Behavioral: Cognitive Behavior TherapyOther: Placebo

Interventions

Fish OilDIETARY_SUPPLEMENT

Omega-3 fatty acid supplements.

Omega-3 Fatty Acids
Cognitive Behavior TherapyBEHAVIORAL

Adolescents receive cognitive behavior therapy.

Omega-3 Fatty AcidsPlacebo
PlaceboOTHER
Placebo

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Fish OilsCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

OilsLipidsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sayed Naqvi, M.D.

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 8, 2008

First Posted

April 15, 2008

Study Start

November 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

March 27, 2012

Record last verified: 2012-03

Locations

US(1)