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

Major Depressive Disorder Clinical Trial

— SADFAT  

Official title:

Supplementation of Antidepressants With Fatty Acid Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00963196
• Other study ID #: 14503
• Status: Withdrawn
• Phase: N/A
• First received: August 20, 2009
• Last updated: June 2, 2010
• Start date: September 2009
• Est. completion date: May 2010

Study information

• Verified date: June 2010
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 78
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Dietary Supplement:
• Omega-3 fatty acid
2400mg daily of fish oil containing 1440mg combined EPA and DHA for 12 weeks

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

Locations

Country	Name	City	State
United States	UVA Psychiatry Outpatient Clinic	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

Hallahan B, Garland MR. Essential fatty acids and mental health. Br J Psychiatry. 2005 Apr;186:275-7. — View 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. Review. — View Citation

Hibbeln JR. Fish consumption and major depression. Lancet. 1998 Apr 18;351(9110):1213. — View 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. Epub 2003 Jun 23. — View 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. — View Citation

Tanskanen A, Hibbeln JR, Hintikka J, Haatainen K, Honkalampi K, Viinamäki H. Fish consumption, depression, and suicidality in a general population. Arch Gen Psychiatry. 2001 May;58(5):512-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in MADRS and PHQ-9 scores occurs in a shorter period of time in the intervention group versus the placebo group.		12 weeks	No
Secondary	Subjects in the intervention group experience greater reduction of scores in MADRS and PHQ-9 than the placebo group.		12 weeks	No