Omega 3 FA Supplements as Augmentation in the Treatment of Depression

NCT ID: NCT01803711

Last Updated: 2017-12-27

Basic Information

• 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

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).

Conditions

Major Depression; Cancer; Diabetes; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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

Pristiq

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jayesh Kamath, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

University of Connecticut Health Center

Farmington, Connecticut, United States

Countries

United States

Other Identifiers

OmegaDVS

Identifier Type: -

Identifier Source: org_study_id