search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number2029
- NTR NumberNTR624
- ISRCTNISRCTN30877831
- Date ISRCTN created28-apr-2006
- date ISRCTN requested25-apr-2006
- Date Registered NTR21-mrt-2006
- Secondary IDsDFN 2004.13.004 
- Public TitleAddition of eicosapentaenoic acid to maintenance anti-depressant therapy in diabetes patients with major depressive disorder: a double-blind, placebo-controlled pilot study.
- Scientific TitleAddition of eicosapentaenoic acid to maintenance anti-depressant therapy in diabetes patients with major depressive disorder: a double-blind, placebo-controlled pilot study.
- ACRONYMOmega-3 fatty acid EPA for depression in diabetes
- hypothesisAddition of eicosapentaenoic acid (1 gram/day) to maintenance anti-depressant therapy in diabetes patients and major depression will be associated with a reduction of depression symptoms, compared to placebo (1 gram grapeseed oils).
- Healt Condition(s) or Problem(s) studiedDepression, Diabetes Mellitus Type 2 (DM type II), Diabetes Mellitus Type 1 (DM type I)
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2006
- planned closingdate1-apr-2007
- Target number of participants30
- Interventions2 capsules containing eicosapentaenoic acid (total amount of 1 gam/day) or placebo.
- Primary outcomeDepression.
- Secondary outcomeGlycemic control.
- TimepointsN/A
- Trial web sitehttp://www.diabetespsychology.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. F. Pouwer
- CONTACT for SCIENTIFIC QUERIESDr. F. Pouwer
- Sponsor/Initiator VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
Dutch Diabetes Research Foundation, Minami Nutrition
- PublicationsN/A
- Brief summaryDepression can be regarded as a common threat to the quality of life of diabetes patients. Evidence strongly suggests that major depression is more prevalent and more persistent in diabetes patients compared to the general population. Depression in diabetes is also associated with impaired glycaemic control, an increased risk for cardiovascular complications and increased health care consumption. Effective pharmacological interventions are available to treat major depression. Yet, in only 50-60% of the depressed subjects with diabetes, pharmacotherapy does lead to remission of depression.
Both depression and diabetes were found to be associated with an impaired fatty acid metabolism. Several animal and epidemiological studies have found that consumption of omega-3 fatty acids is associated with a decreased risk for depression. Three randomised controlled trials in non-diabetic subjects demonstrated that omega-3 fatty acids as add-on therapy is effective in treating major depression, whereas one trial found that monotherapy with docosahexaenoic acid is not. So far, interventions in diabetes patients are lacking. The omega-3 fatty acids have three main advantages: 1) they are relatively inexpensive, 2) generally well tolerated by patients and 3) decrease the risk of cardiovascular disease. The available evidence warrants a trial with omega-3 PUFA in particular in the diabetic population, that has a high prevalence of treatment-resistant depression. The currently proposed randomised double-blind, placebo-controlled pilot add-on study will be the first to test this hypothesis in diabetes patients suffering from current major depression and to determine underlying physiological mechanisms.
- Main changes (audit trail)
- RECORD21-mrt-2006 - 24-nov-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl