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Study of Supplementation of Antidepressants With Fish Oil to Improve Time to Clinical Response (SADFAT)

Primary Purpose

Major Depressive Disorder

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Omega-3 fatty acid

Bovine gelatin capsules

About this trial

This is an interventional supportive care trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Major Depressive Disorder.
Allowed comorbidities: Dysthymia, Anxiety Disorders.
18 years old or older.
Males + Females.
English-speaking.
Women of reproductive age must be on adequate birth control, either oral contraceptives or using condoms or other barrier methods with spermicidal agents.
Subjects may be undergoing psychotherapy, but must maintain current psychotherapy status. Must not start therapy if not already in therapy. If in therapy, must have received at least 6 sessions prior to entering the study.
Subjects may continue taking herbals or supplements during the study, but they may not start any new herbals or supplements during the study.

Exclusion Criteria:

2 or more failed trials of antidepressants (adequate dose and duration, and documented).
Substance dependence in the past 6 months.
Current substance use or abuse (MJ, benzodiazepines, narcotics). If BZD use, patient must be tapered off and wait 1 month before being included in the trial.
Psychosis.
Bipolar Affective Disorder Type I, II or NOS.
Pregnancy (current or planned).
Unstable medical illness (pt has to be stable for at least 3 months, and may be excluded per investigator discretion).
Dementia.
Mental retardation.
Traumatic Brain Injury.
History of Stroke.
History of seizure disorder.
Electroconvulsive therapy within past 6 months.
If, at the investigator's discretion, it is suspected that the subject will likely not comply with the study protocol.
Imminent risk for suicide.

Sites / Locations

UVA Psychiatry Outpatient Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

One unsuccessful trial

One successful trial

No previous trial

Arm Description

Patients with one unsuccessful previous antidepressant trial

Patients with one previous successful antidepressant trial

Patients with no prior antidepressant therapy

Outcomes

Primary Outcome Measures

Improvement in MADRS and PHQ-9 scores occurs in a shorter period of time in the intervention group versus the placebo group.

Secondary Outcome Measures

Subjects in the intervention group experience greater reduction of scores in MADRS and PHQ-9 than the placebo group.

Full Information

NCT ID

NCT00963196

First Posted

August 20, 2009

Last Updated

June 2, 2010

Sponsor

University of Virginia

1. Study Identification

Unique Protocol Identification Number

NCT00963196

Brief Title

Study of Supplementation of Antidepressants With Fish Oil to Improve Time to Clinical Response

Acronym

SADFAT

Official Title

Supplementation of Antidepressants With Fatty Acid Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Withdrawn

Why Stopped

End of allotted time for subject recruiting.

Study Start Date

September 2009 (undefined)

Primary Completion Date

May 2010 (Anticipated)

Study Completion Date

May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Virginia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will be a randomized controlled trial set in an outpatient clinic, involving patients with major depressive disorder, who will be treated with antidepressant therapy, which will be individually agreed upon by the subject and his or her physician. Patients will be randomized to receive either placebo or fish oil capsules containing eicosapentaenoic acid (EHA) and docosahexaenoic acid (DHA) in addition to their antidepressant medication. Subjects will complete a brief dietary and exercise habits survey at the beginning of the trial to take into account lifestyle factors that may be significant in symptom resolution. Their progress will be monitored over a period of twelve weeks, with standardized rating scales completed by subjects and treating physicians. At the end of the study, scores will be compared between groups to look for differences in timing and degree of symptom improvement to analyze whether improvement occurred faster in the group receiving essential fatty acids (EFAs) than in the one receiving placebo. The primary hypothesis is that supplementation of antidepressant therapy with omega-3 fatty acids will decrease the lag period between the start of therapy and the time of clinically significant symptom improvement. A secondary hypothesis is that the results of this study will be consistent with numerous previous studies showing improvement in symptom control in major depressive disorder when antidepressants are supplemented with omega-3 fatty acids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

One unsuccessful trial

Arm Type

Active Comparator

Arm Description

Patients with one unsuccessful previous antidepressant trial

Arm Title

One successful trial

Arm Type

Active Comparator

Arm Description

Patients with one previous successful antidepressant trial

Arm Title

No previous trial

Arm Type

Active Comparator

Arm Description

Patients with no prior antidepressant therapy

Intervention Type

Dietary Supplement

Intervention Name(s)

Omega-3 fatty acid

Intervention Description

2400mg daily of fish oil containing 1440mg combined EPA and DHA for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Bovine gelatin capsules

Intervention Description

Bovine gelatin capsules that appear similar to active drug acting as placebo.

Primary Outcome Measure Information:

Title

Improvement in MADRS and PHQ-9 scores occurs in a shorter period of time in the intervention group versus the placebo group.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Subjects in the intervention group experience greater reduction of scores in MADRS and PHQ-9 than the placebo group.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Major Depressive Disorder. Allowed comorbidities: Dysthymia, Anxiety Disorders. 18 years old or older. Males + Females. English-speaking. Women of reproductive age must be on adequate birth control, either oral contraceptives or using condoms or other barrier methods with spermicidal agents. Subjects may be undergoing psychotherapy, but must maintain current psychotherapy status. Must not start therapy if not already in therapy. If in therapy, must have received at least 6 sessions prior to entering the study. Subjects may continue taking herbals or supplements during the study, but they may not start any new herbals or supplements during the study. Exclusion Criteria: 2 or more failed trials of antidepressants (adequate dose and duration, and documented). Substance dependence in the past 6 months. Current substance use or abuse (MJ, benzodiazepines, narcotics). If BZD use, patient must be tapered off and wait 1 month before being included in the trial. Psychosis. Bipolar Affective Disorder Type I, II or NOS. Pregnancy (current or planned). Unstable medical illness (pt has to be stable for at least 3 months, and may be excluded per investigator discretion). Dementia. Mental retardation. Traumatic Brain Injury. History of Stroke. History of seizure disorder. Electroconvulsive therapy within past 6 months. If, at the investigator's discretion, it is suspected that the subject will likely not comply with the study protocol. Imminent risk for suicide.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anita H Clayton, MD

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

UVA Psychiatry Outpatient Clinic

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15802681

Citation

Hallahan B, Garland MR. Essential fatty acids and mental health. Br J Psychiatry. 2005 Apr;186:275-7. doi: 10.1192/bjp.186.4.275. No abstract available.

Results Reference

background

PubMed Identifier

15301790

Citation

Hallahan B, Garland MR. Essential fatty acids and their role in the treatment of impulsivity disorders. Prostaglandins Leukot Essent Fatty Acids. 2004 Oct;71(4):211-6. doi: 10.1016/j.plefa.2004.03.006.

Results Reference

background

PubMed Identifier

9643729

Citation

Hibbeln JR. Fish consumption and major depression. Lancet. 1998 Apr 18;351(9110):1213. doi: 10.1016/S0140-6736(05)79168-6. No abstract available.

Results Reference

background

PubMed Identifier

12091259

Citation

Gesch CB, Hammond SM, Hampson SE, Eves A, Crowder MJ. Influence of supplementary vitamins, minerals and essential fatty acids on the antisocial behaviour of young adult prisoners. Randomised, placebo-controlled trial. Br J Psychiatry. 2002 Jul;181:22-8. doi: 10.1192/bjp.181.1.22.

Results Reference

background

PubMed Identifier

12821543

Citation

Pischon T, Hankinson SE, Hotamisligil GS, Rifai N, Willett WC, Rimm EB. Habitual dietary intake of n-3 and n-6 fatty acids in relation to inflammatory markers among US men and women. Circulation. 2003 Jul 15;108(2):155-60. doi: 10.1161/01.CIR.0000079224.46084.C2. Epub 2003 Jun 23.

Results Reference

background

PubMed Identifier

10232294

Citation

Stoll AL, Severus WE, Freeman MP, Rueter S, Zboyan HA, Diamond E, Cress KK, Marangell LB. Omega 3 fatty acids in bipolar disorder: a preliminary double-blind, placebo-controlled trial. Arch Gen Psychiatry. 1999 May;56(5):407-12. doi: 10.1001/archpsyc.56.5.407.

Results Reference

background

PubMed Identifier

11343534

Citation

Tanskanen A, Hibbeln JR, Hintikka J, Haatainen K, Honkalampi K, Viinamaki H. Fish consumption, depression, and suicidality in a general population. Arch Gen Psychiatry. 2001 May;58(5):512-3. doi: 10.1001/archpsyc.58.5.512. No abstract available.

Results Reference

background

PubMed Identifier

34817851

Citation

Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.

Results Reference

derived

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