Omega-3 Fatty Acids for Treatment of Depression in Adoles... | NCT00658476

Studies
Omega-3 Fatty Acids for Treatment of Depression in Adolescents

NCT00658476

Sponsor

Cedars-Sinai Medical Center

Status

Completed

Last Update Posted

Mar 27, 2012Estimated

Enrollment

4Actual

Phase

Phase 3

Conditions

Depression

Interventions

Fish Oil
Cognitive Behavior Therapy
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Apr 8, 2008

First Submission Date that Met QC Criteria

Apr 14, 2008

First Posted Date

Apr 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2012

Last Update Posted Date

Mar 27, 2012Estimated

Name	Class
National Alliance for Research on Schizophrenia and Depression	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omega-3 Fatty Acids	Experimental	Adolescents receive cognitive behavior therapy in combination with Omega-3 fatty acid supplements.	Dietary Supplement: Fish Oil Behavioral: Cognitive Behavior Therapy
Placebo	Placebo Comparator	Adolescents receive cognitive behavior therapy in combination with placebo.	Behavioral: Cognitive Behavior Therapy Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fish Oil	Dietary Supplement	Omega-3 fatty acid supplements.	Omega-3 Fatty Acids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Child Depression Inventory - CDI		8 times for an average of 8 weeks
Hamilton Depression Rating Scale		8 times for an average of 8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Sayed Naqvi, M.D.	Cedars-Sinai Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center		Los Angeles	California	90048	United States

ID	Term
D003863	Depression

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D005395	Fish Oils
D015928	Cognitive Behavioral Therapy

Ancestor Terms

ID	Term
D009821	Oils
D008055	Lipids
D001521	Behavior Therapy
D011613	Psychotherapy
D004191

Browse Leaves

Not provided

Browse Branches

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