Omega 3 FA Supplements as Augmentation in the Treatment of Depression

Study Overview
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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).

Official Title
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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.

Conditions
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Major Depression, Cancer, Diabetes, Cardiovascular Diseases

Intervention / Treatment
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* Drug: Desvenlafaxine
* Dietary Supplement: Omega 3 Fatty acids
* Drug: Placebo (for Omega 3 fatty acid supplement)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desvenlafaxine + Omega 3 FA supplement<br>Desvenlafaxine 50mg/day & Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period | Drug: Desvenlafaxine<br> <br> * Other names: Pristiq;Dietary Supplement: Omega 3 Fatty acids<br> <br> |
| Active Comparator: Desvenlafaxine + Placebo (for Omega 3 FA supplement)<br>Desvenlafaxine 50mg/day & Placebo (for Omega 3 FA supplement) over a 12 week period | Drug: Desvenlafaxine<br> <br> * Other names: Pristiq;Drug: Placebo (for Omega 3 fatty acid supplement)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS) |  | 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 | 
| Leeds Sleep Evaluation Questionnaire (LSEQ) |  | 12 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega 3 fatty acid, Fish oil, Depression, cancer, diabetes, high blood pressure, cardiovascular