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

This study has been withdrawn prior to enrollment.
(End of allotted time for subject recruiting.)
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00963196
First received: August 20, 2009
Last updated: June 2, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Dietary Supplement: Omega-3 fatty acid
Drug: Bovine gelatin capsules

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Supplementation of Antidepressants With Fatty Acid Therapy

Resource links provided by NLM:


Further study details as provided by University of Virginia:

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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjects in the intervention group experience greater reduction of scores in MADRS and PHQ-9 than the placebo group. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: September 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: One unsuccessful trial
Patients with one unsuccessful previous antidepressant trial
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.
Active Comparator: One successful trial
Patients with one previous successful antidepressant trial
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.
Active Comparator: No previous trial
Patients with no prior antidepressant therapy
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963196

Locations
United States, Virginia
UVA Psychiatry Outpatient Clinic
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Anita H Clayton, MD University of Virginia
  More Information

Additional Information:
Publications:
Responsible Party: Anita Clayton MD, University of Virginia Department of Psychiatry and Neurobehavioral Sciences
ClinicalTrials.gov Identifier: NCT00963196     History of Changes
Other Study ID Numbers: 14503
Study First Received: August 20, 2009
Last Updated: June 2, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014