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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.


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Major Depression, Cancer, Diabetes, Cardiovascular Diseases

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Hospital Anxiety and Depression Scale

Outcome Time Frame:

12 weeks from baseline

Safety Issue:

No

Principal Investigator

Jayesh Kamath, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Connecticut Health Center

Authority:

United States: Food and Drug Administration

Study ID:

OmegaDVS

NCT ID:

NCT01803711

Start Date:

February 2013

Completion Date:

February 2015

Related Keywords:

  • Major Depression
  • Cancer
  • Diabetes
  • Cardiovascular Diseases
  • Omega 3 fatty acid
  • Fish oil
  • Depression
  • cancer
  • diabetes
  • high blood pressure
  • cardiovascular
  • Cardiovascular Diseases
  • Depression
  • Depressive Disorder
  • Diabetes Mellitus
  • Depressive Disorder, Major

Name

Location

University of Connecticut Health CenterFarmington, Connecticut  06360-7106