Status:
TERMINATED
Omega 3 FA Supplements as Augmentation in the Treatment of Depression
Lead Sponsor:
UConn Health
Conditions:
Major Depression
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
To assess the efficacy of Omega 3 Fatty acid (Omega 3 FA) augmentation of desvenlafaxine (DVS) compared to placebo augmentation of DVS when used to treat depression and anxiety symptoms in patients wi...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Diagnosed with depression and have cardiovascular disease, diabetes or cancer.
- Able to provide written informed consent prior to initiation of any study-related procedures.
- Able to understand and comply with the requirements of the study.
Exclusion
- Hospitalized patients or psychotherapy for depression begun within 4 weeks.
- Patients with medically reversible causes of depression (e.g. hypothyroidism).
- Patients with significant comorbid symptoms (e.g. pain, insomnia) that have a direct causal relation to depressive and anxiety symptoms with these comorbid symptoms dominating the clinical scenario. Patients will be enrolled in the study if these comorbid symptoms merely coexist with depressive and anxiety symptoms and are not dominating the clinical scenario as judged by the study investigator
- Patients with an identifiable diagnosis of substance abuse or dependence within 6 months prior to evaluation (except those in full remission, or those with caffeine or nicotine dependence) as defined by DSM-IV criteria.
- Patients with any clinically significant unstable or inadequately treated co-morbid medical condition which, in the opinion of the investigator, would make the patient unsuited for the study
- Patients with currently active or with significant history of other clinically significant psychiatric disorders such as bipolar disorder, schizophrenia etc.
- Pregnant patients, breastfeeding or those planning to become pregnant during the study.
- Any other condition, which, in the opinion of the investigator, would make the patient, unsuited for enrollment in the study, including known or suspect history of allergy to fish oil, fish or desvenlafaxine.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01803711
Start Date
February 1 2013
End Date
June 1 2016
Last Update
December 27 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030