Omega 3 FA Supplements as Augmentation in the Treatment of Depression

UConn Health

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Diabetes; Major Depression; Cardiovascular Diseases; Cancer

Treatments: Drug: Desvenlafaxine; Drug: Placebo (for Omega 3 fatty acid supplement); Dietary Supplement: Omega 3 Fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT01803711

OmegaDVS

Details and patient eligibility

About

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).

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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6 participants in 2 patient groups

Desvenlafaxine + Omega 3 FA supplement

Experimental group

Description:

Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period

Treatment:

Dietary Supplement: Omega 3 Fatty acids

Drug: Desvenlafaxine

Desvenlafaxine + Placebo (for Omega 3 FA supplement)

Active Comparator group

Description:

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

Treatment:

Drug: Desvenlafaxine

Drug: Placebo (for Omega 3 fatty acid supplement)