This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Omega 3 FA Supplements as Augmentation in the Treatment of Depression

This study has been terminated.
(Lack of recruitment and no resources)
Information provided by (Responsible Party):
UConn Health Identifier:
First received: February 28, 2013
Last updated: March 3, 2016
Last verified: March 2016
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 with select medical conditions (cancer, cardiovascular diseases and diabetes).

Condition Intervention Phase
Major Depression Cancer Diabetes Cardiovascular Diseases Drug: Desvenlafaxine Dietary Supplement: Omega 3 Fatty acids Drug: Placebo (for Omega 3 fatty acid supplement) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Placebo-controlled Study Evaluating the Efficacy of Omega 3 Fatty Acid Augmentation of Desvenlafaxine for the Treatment of Major Depressive Disorder in Patients With Medical Illness.

Resource links provided by NLM:

Further study details as provided by UConn Health:

Primary Outcome Measures:
  • Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks from baseline ]

Secondary Outcome Measures:
  • Montgomery-Asberg depression rating scale (MADRS). [ Time Frame: 12 weeks from baseline ]
  • short form health survey (SF-12) [ Time Frame: 12 weeks from baseline ]
  • visual analog scale for energy (VAS-E) [ Time Frame: 12 weeks from baseline ]
  • visual analog scale for pain (VAS-P) [ Time Frame: 12 weeks from baseline ]
  • Leeds sleep evaluation questionnaire (LSEQ) [ Time Frame: 12 weeks from baseline ]

Enrollment: 6
Study Start Date: February 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desvenlafaxine + Omega 3 FA supplement
Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period
Drug: Desvenlafaxine
Other Name: Pristiq
Dietary Supplement: Omega 3 Fatty acids
Active Comparator: Desvenlafaxine + Placebo (for Omega 3 FA supplement)
Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period
Drug: Desvenlafaxine
Other Name: Pristiq
Drug: Placebo (for Omega 3 fatty acid supplement)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  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 identifier: NCT01803711

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Principal Investigator: Jayesh Kamath, MD PhD UConn Health
  More Information

Responsible Party: UConn Health Identifier: NCT01803711     History of Changes
Other Study ID Numbers: OmegaDVS
Study First Received: February 28, 2013
Last Updated: March 3, 2016

Keywords provided by UConn Health:
Omega 3 fatty acid
Fish oil
high blood pressure

Additional relevant MeSH terms:
Depressive Disorder
Cardiovascular Diseases
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs processed this record on September 21, 2017