Clinical trial NCT01803711: Omega 3 FA Supplements as Augmentation in the Treatment of Depression
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Major Depression
Cancer
Diabetes
Cardiovascular Diseases
Keywords: Omega 3 fatty acid
Fish oil
Depression
cancer
diabetes
high blood pressure
cardiovascular
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2013-03-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: 12 weeks from baseline
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: 12 weeks from baseline
measure: Short Form Health Survey (SF-12)
timeFrame: 12 weeks from baseline
measure: Visual Analog Scale for Energy (VAS-E)
timeFrame: 12 weeks from baseline
measure: Visual Analog Scale for Pain (VAS-P)
timeFrame: 12 weeks from baseline
measure: Leeds Sleep Evaluation Questionnaire (LSEQ)
timeFrame: 12 weeks from baseline
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Jayesh Kamath, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: