Omega 3 FA Supplements as Augmentation in the Treatment of Depression

Cancer Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01803711
• Other study ID #: OmegaDVS
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: February 28, 2013
• Last updated: November 30, 2017
• Start date: February 2013
• Est. completion date: June 2016

Study information

• Verified date: November 2017
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Diseases
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Diabetes
• Major Depression

Intervention

Drug:
• Desvenlafaxine

Dietary Supplement:
• Omega 3 Fatty acids

Drug:
• Placebo (for Omega 3 fatty acid supplement)

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
UConn Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Montgomery-Asberg Depression Rating Scale (MADRS)		12 weeks from baseline
Secondary	Short Form Health Survey (SF-12)		12 weeks from baseline
Secondary	Visual Analog Scale for Energy (VAS-E)		12 weeks from baseline
Secondary	Visual Analog Scale for Pain (VAS-P)		12 weeks from baseline
Secondary	Leeds Sleep Evaluation Questionnaire (LSEQ)		12 weeks from baseline