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SAM study: An epigenetic therapy for depression after childhood trauma


- candidate number27215
- NTR NumberNTR6302
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-mei-2017
- Secondary IDs62020 ABR
- Public TitleSAM study: An epigenetic therapy for depression after childhood trauma
- Scientific TitleSAMe as an epigenetic treatment of depression in people with bipolar disorder and childhood trauma, a double blind placebo-controlled trial
- ACRONYMSAM study
- hypothesisWe 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
- Healt Condition(s) or Problem(s) studiedDepression, Bipolar disorder, Childhood trauma
- Inclusion criteria1. 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.
- Exclusion criteria1. 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2017
- planned closingdate1-dec-2020
- Target number of participants100
- InterventionsS-adenosyl-L-methionine 12 weeks, oral, 1200 mg daily, versus placebo
- Primary outcome50 percent reduction of 50% or more of the Hamilton Depression Rating Scale
- Secondary outcomeMADRS, genome-wide DNA methylation and KITLG methylation, Altered stress resilience
- TimepointsT0 before intervention, T1 immediately after invention, and 6 months monthly follow-up.
- Trial web sitewww.umcutrecht.nl/hersencentrum/samstudie
- statusplanned
- CONTACT FOR PUBLIC QUERIES Geertje De Lange
- CONTACT for SCIENTIFIC QUERIES Marco Boks
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZonMw, Hersenstichting Nederland
- Publications
- Brief summaryA clinical trial on effects of SAMe on depression and DNA methylation in bipolar disorder patients with a history of childhood trauma. In the Netherlands.
- Main changes (audit trail)
- RECORD16-mei-2017 - 11-jun-2017


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