Omega 3 FA Supplements as Augmentation in the Treatment of Depression

Phase 2

Terminated

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

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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Desvenlafaxine + Omega 3 FA supplement	Omega 3 Fatty acids	Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period
Desvenlafaxine + Placebo (for Omega 3 FA supplement)	Placebo (for Omega 3 fatty acid supplement)	Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period
Desvenlafaxine + Omega 3 FA supplement	Desvenlafaxine	Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period
Desvenlafaxine + Placebo (for Omega 3 FA supplement)	Desvenlafaxine	Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	12 weeks from baseline	Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.

Secondary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS)	12 weeks from baseline
Leeds Sleep Evaluation Questionnaire (LSEQ)	12 weeks from baseline
Short Form Health Survey (SF-12)	12 weeks from baseline
Visual Analog Scale for Energy (VAS-E)	12 weeks from baseline
Visual Analog Scale for Pain (VAS-P)	12 weeks from baseline