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Omega 3 FA Supplements as Augmentation in the Treatment of Depression

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ClinicalTrials.gov Identifier: NCT01803711
Recruitment Status : Terminated (Lack of recruitment and no resources)
First Posted : March 4, 2013
Results First Posted : December 27, 2017
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
UConn Health

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 with select medical conditions (cancer, cardiovascular diseases and diabetes).

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 6 participants
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.
Study Start Date : February 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks from baseline ]
    Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.


Secondary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 weeks from baseline ]
  2. Short Form Health Survey (SF-12) [ Time Frame: 12 weeks from baseline ]
  3. Visual Analog Scale for Energy (VAS-E) [ Time Frame: 12 weeks from baseline ]
  4. Visual Analog Scale for Pain (VAS-P) [ Time Frame: 12 weeks from baseline ]
  5. Leeds Sleep Evaluation Questionnaire (LSEQ) [ Time Frame: 12 weeks from baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803711


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

Responsible Party: UConn Health
ClinicalTrials.gov Identifier: NCT01803711     History of Changes
Other Study ID Numbers: OmegaDVS
First Posted: March 4, 2013    Key Record Dates
Results First Posted: December 27, 2017
Last Update Posted: December 27, 2017
Last Verified: November 2017

Keywords provided by UConn Health:
Omega 3 fatty acid
Fish oil
Depression
cancer
diabetes
high blood pressure
cardiovascular

Additional relevant MeSH terms:
Depression
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