Status:
WITHDRAWN
Study of Supplementation of Antidepressants With Fish Oil to Improve Time to Clinical Response
Lead Sponsor:
University of Virginia
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
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 individu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00963196
Start Date
September 1 2009
End Date
May 1 2010
Last Update
June 4 2010
Active Locations (1)
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1
UVA Psychiatry Outpatient Clinic
Charlottesville, Virginia, United States, 22908