We hypothesize that the epigenetic changes that are related to childhood trauma provide a treatment target for succesful treatment with SAMe of persistent depression in bipolar disorder
ID
Bron
Verkorte titel
Aandoening
bipolar disorder; depression; DNA methylation; childhood trauma; SAMe; S-adenosyl-L-methionine; epigenetic
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
50 percent reduction of 50% or more of the Hamilton Depression Rating Scale
Achtergrond van het onderzoek
A clinical trial on effects of SAMe on depression and DNA methylation in bipolar disorder patients with a history of childhood trauma. In the Netherlands.
Doel van het onderzoek
We hypothesize that the epigenetic changes that are related to childhood trauma provide a treatment target for succesful treatment with SAMe of persistent depression in bipolar disorder
Onderzoeksopzet
T0 before intervention, T1 immediately after invention, and 6 months monthly follow-up.
Onderzoeksproduct en/of interventie
S-adenosyl-L-methionine 12 weeks, oral, 1200 mg daily, versus placebo
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Diagnosis of bipolar disorder as defined by DSM-IV-R as determined by the SCID.
2. Age 18 -65 years.
3. Stable medication use (in the last 6 months).
4. Current depressive episode as defined by a HAM-D score of at least 16.
5. High levels of childhood trauma measured by the CTQ (Bernstein et al., 2003).
6. Suitable for EMDR treatment.
7. Capable of providing written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Psychiatric admission in the past six months
2. Compulsory admission or treatment under Dutch law (BOPZ)
3. Major somatic disorder interfering with treatment or diagnosis
4. Pregnancy or breastfeeding
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6147 |
| NTR-old | NTR6302 |
| Ander register | ABR : 62020 |