Addition of eicosapentaenoic acid to maintenance anti-depressant therapy in diabetes patients with major depressive disorder: a double-blind, placebo-controlled pilot study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28433

Enrollment

Registered

2006-03-21

Start date

2006-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depression, diabetes

Interventions

2 capsules containing eicosapentaenoic acid (total amount of 1 gam/day) or placebo.

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18-75 years old; 2. Having diabetes; 3. Current diagnosis of major depressive disorder that is being treated with ongoing anti-depressant medication; and 4. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Psychotic features; 2. History of (hypo) mania; 3. An average consumption of fish higher than 2 servings per week or current daily use of fish oil supplements; 4. Active suicidal ideation or a history of suicide attempt; 5. Allergy for fish or fish products; 6. Pregnancy.

Design outcomes

Primary

Measure	Time frame
Depression.	—

Secondary

Measure	Time frame
Glycemic control.	—

Contacts

Public ContactF. Pouwer

VU University Medical Center, Department of Medical Psychology, Diabetes Psychology Research Group, Van der Boechorststraat 7

f.pouwer@vumc.nl+31 (0)20 4449679

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)