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Clinical Trial Details
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Omega 3 Fatty Acid Augmentation of Desvenlafaxine Treatment of Major Depressive Disorder in Patients with Medical Illness
Clinical Trial ( IRB ) #: 12-231-2
Title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Omega 3 Fatty Acid Augmentation of Desvenlafaxine Treatment of Major Depressive Disorder in Patients with Medical Illness
Principal Investigator: Dr. Jayesh Kamath
Description: The primary aim of this pilot, randomized, double-blind placebo-controlled trial is 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 Major Depressive Disorder (MDD) and anxiety symptoms in patients with select medical conditions (cancer, diabetes and cardiovascular disease) as measured by the hospital anxiety and depression scale (HADS) and the Montgomery-Asberg depression rating scale (MADRS). The secondary aims are: to assess the efficacy of Omega 3 FA augmentation of DVS compared to placebo augmentation of DVS on quality of life as measured by the short form health survey (SF-12); to assess pain symptoms as measured by the visual analog scale for pain (VAS-P); to assess fatigue as measured by the visual analog scale for energy (VAS-E) and; to assess the impact on sleep disturbances as measured by the Leeds sleep evaluation questionnaire (LSEQ). The exploratory aims are to assess the impact of Omega 3 FA augmentation versus placebo augmentation of DVS on inflammation as measured by specific inflammatory markers levels in serum i.e. C-reactive protein, IL-6, TNF-a and; to assess HPA axis regulation as measured by salivary cortisol levels.
Classification:
  Mental Health (Depression, Anxiety, Etc.)
  Psychiatry - General Adult/Mental Health (Depression, Anxiety, Etc.)
Eligibility Criteria: Check with study contact
How to Contact: Oluwanisola Odesina. Telephone: Not available. Email: Oodesina@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.