Omega 3 FA Supplements as Augmentation in the Treatment of Depression
Primary Purpose
Major Depression, Cancer, Diabetes
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Desvenlafaxine
Omega 3 Fatty acids
Placebo (for Omega 3 fatty acid supplement)
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression focused on measuring Omega 3 fatty acid, Fish oil, Depression, cancer, diabetes, high blood pressure, cardiovascular
Eligibility 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.
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Desvenlafaxine + Omega 3 FA supplement
Desvenlafaxine + Placebo (for Omega 3 FA supplement)
Arm Description
Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period
Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period
Outcomes
Primary Outcome Measures
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.
Secondary Outcome Measures
Montgomery-Asberg Depression Rating Scale (MADRS)
Short Form Health Survey (SF-12)
Visual Analog Scale for Energy (VAS-E)
Visual Analog Scale for Pain (VAS-P)
Leeds Sleep Evaluation Questionnaire (LSEQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01803711
Brief Title
Omega 3 FA Supplements as Augmentation in the Treatment of Depression
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 Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment and no resources
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Cancer, Diabetes, Cardiovascular Diseases
Keywords
Omega 3 fatty acid, Fish oil, Depression, cancer, diabetes, high blood pressure, cardiovascular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desvenlafaxine + Omega 3 FA supplement
Arm Type
Experimental
Arm Description
Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period
Arm Title
Desvenlafaxine + Placebo (for Omega 3 FA supplement)
Arm Type
Active Comparator
Arm Description
Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine
Other Intervention Name(s)
Pristiq
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega 3 Fatty acids
Intervention Type
Drug
Intervention Name(s)
Placebo (for Omega 3 fatty acid supplement)
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale
Description
Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.
Time Frame
12 weeks from baseline
Secondary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame
12 weeks from baseline
Title
Short Form Health Survey (SF-12)
Time Frame
12 weeks from baseline
Title
Visual Analog Scale for Energy (VAS-E)
Time Frame
12 weeks from baseline
Title
Visual Analog Scale for Pain (VAS-P)
Time Frame
12 weeks from baseline
Title
Leeds Sleep Evaluation Questionnaire (LSEQ)
Time Frame
12 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayesh Kamath, MD PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Omega 3 FA Supplements as Augmentation in the Treatment of Depression
We'll reach out to this number within 24 hrs