Omega 3 FA Supplements as Augmentation in the Treatment of Depression

NCT01803711 | Terminated Phase 2 Results DMC

• 1 other identifier: OmegaDVS
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depression; Cancer; Diabetes; Cardiovascular Diseases

Keywords

Omega 3 fatty acid; Fish oil; Depression; cancer; diabetes; high blood pressure; cardiovascular

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Desvenlafaxine + Omega 3 FA supplement

EXPERIMENTAL

Desvenlafaxine 50mg/day \& Omega 3 FA supplement (range 2.4 gm/day - 4.8 gm day) over a 12 week period

Drug: Desvenlafaxine; Dietary Supplement: Omega 3 Fatty acids

Desvenlafaxine + Placebo (for Omega 3 FA supplement)

ACTIVE COMPARATOR

Desvenlafaxine 50mg/day \& Placebo (for Omega 3 FA supplement) over a 12 week period

Drug: Desvenlafaxine; Drug: Placebo (for Omega 3 fatty acid supplement)

Interventions

Desvenlafaxine DRUG

Also known as: Pristiq

Desvenlafaxine + Omega 3 FA supplement; Desvenlafaxine + Placebo (for Omega 3 FA supplement)

Omega 3 Fatty acids DIETARY_SUPPLEMENT

Desvenlafaxine + Omega 3 FA supplement

Placebo (for Omega 3 fatty acid supplement) DRUG

Desvenlafaxine + Placebo (for Omega 3 FA supplement)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Neoplasms; Diabetes Mellitus; Cardiovascular Diseases; Depression; Hypertension

Interventions

Desvenlafaxine Succinate; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Limitations and Caveats

Due to very low enrollment in both arms, only descriptive analyses was completed for both arms

Results Point of Contact

• Title: Jayesh Kamath MD PhD
• Organization: UConn Health Center

jkamath@uchc.edu

8606796727

Study Officials

• Jayesh Kamath, MD PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 4, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 27, 2017
• Results First Posted: December 27, 2017

Record last verified: 2017-11

Locations

US (1)