- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01803711
Omega 3 FA Supplements as Augmentation in the Treatment of Depression
November 30, 2017 updated by: UConn Health
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.
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
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Farmington, Connecticut, United States, 06030
- University of Connecticut Health Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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
|
Other Names:
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Active Comparator: Desvenlafaxine + Placebo (for Omega 3 FA supplement)
Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period
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Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks from baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 12 weeks from baseline
|
12 weeks from baseline
|
Short Form Health Survey (SF-12)
Time Frame: 12 weeks from baseline
|
12 weeks from baseline
|
Visual Analog Scale for Energy (VAS-E)
Time Frame: 12 weeks from baseline
|
12 weeks from baseline
|
Visual Analog Scale for Pain (VAS-P)
Time Frame: 12 weeks from baseline
|
12 weeks from baseline
|
Leeds Sleep Evaluation Questionnaire (LSEQ)
Time Frame: 12 weeks from baseline
|
12 weeks from baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jayesh Kamath, MD PhD, UCONN Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
February 28, 2013
First Submitted That Met QC Criteria
March 1, 2013
First Posted (Estimate)
March 4, 2013
Study Record Updates
Last Update Posted (Actual)
December 27, 2017
Last Update Submitted That Met QC Criteria
November 30, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Cardiovascular Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Desvenlafaxine Succinate
Other Study ID Numbers
- OmegaDVS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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