Omega 3 FA Supplements as Augmentation in the Treatment of Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Connecticut Health Center
Sponsor:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01803711
First received: February 28, 2013
Last updated: March 1, 2013
Last verified: February 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 University of Connecticut Health Center:

Primary Outcome Measures:
  • Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks from baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Montgomery-Asberg depression rating scale (MADRS). [ Time Frame: 12 weeks from baseline ] [ Designated as safety issue: No ]
  • short form health survey (SF-12) [ Time Frame: 12 weeks from baseline ] [ Designated as safety issue: No ]
  • visual analog scale for energy (VAS-E) [ Time Frame: 12 weeks from baseline ] [ Designated as safety issue: No ]
  • visual analog scale for pain (VAS-P) [ Time Frame: 12 weeks from baseline ] [ Designated as safety issue: No ]
  • Leeds sleep evaluation questionnaire (LSEQ) [ Time Frame: 12 weeks from baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01803711

Contacts
Contact: Jayesh Kamath, MD PhD 860-679-6727 jkamath@uchc.edu
Contact: Oluwanisola Odesina 860-679-8931 oodesina@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030
Contact: Jayesh Kamath, MD PhD    860-679-6727    jkamath@uchc.edu   
Contact: Oluwanisola Odesina    860-679-8931    oodesina@uchc.edu   
Principal Investigator: Jayesh Kamath, MD PhD         
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Jayesh Kamath, MD PhD University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01803711     History of Changes
Other Study ID Numbers: OmegaDVS
Study First Received: February 28, 2013
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Connecticut Health Center:
Omega 3 fatty acid
Fish oil
Depression
cancer
diabetes
high blood pressure
cardiovascular

Additional relevant MeSH terms:
Cardiovascular Diseases
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
O-desmethylvenlafaxine
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014