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Omega 3 FA Supplements as Augmentation in the Treatment of Depression

NCT ID: NCT01803711

Last Updated: 2017-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Major Depression Cancer Diabetes Cardiovascular Diseases

Keywords

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Omega 3 fatty acid Fish oil Depression cancer diabetes high blood pressure cardiovascular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Desvenlafaxine

Intervention Type DRUG

Omega 3 Fatty acids

Intervention Type DIETARY_SUPPLEMENT

Desvenlafaxine + Placebo (for Omega 3 FA supplement)

Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period

Group Type ACTIVE_COMPARATOR

Desvenlafaxine

Intervention Type DRUG

Placebo (for Omega 3 fatty acid supplement)

Intervention Type DRUG

Interventions

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Desvenlafaxine

Intervention Type DRUG

Omega 3 Fatty acids

Intervention Type DIETARY_SUPPLEMENT

Placebo (for Omega 3 fatty acid supplement)

Intervention Type DRUG

Other Intervention Names

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Pristiq

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jayesh Kamath, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

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University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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OmegaDVS

Identifier Type: -

Identifier Source: org_study_id