|- candidate number||27215|
|- NTR Number||NTR6302|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-mei-2017|
|- Secondary IDs||62020 ABR|
|- Public Title||SAM study: An epigenetic therapy for depression after childhood trauma|
|- Scientific Title||SAMe as an epigenetic treatment of depression in people with bipolar disorder and childhood trauma, a double blind placebo-controlled trial
|- ACRONYM||SAM study|
|- hypothesis||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|
|- Healt Condition(s) or Problem(s) studied||Depression, Bipolar disorder, Childhood trauma|
|- Inclusion criteria||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.
|- Exclusion criteria||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
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2017|
|- planned closingdate||1-dec-2020|
|- Target number of participants||100|
|- Interventions||S-adenosyl-L-methionine 12 weeks, oral, 1200 mg daily, versus placebo|
|- Primary outcome||50 percent reduction of 50% or more of the Hamilton Depression Rating Scale|
|- Secondary outcome||MADRS, genome-wide DNA methylation and KITLG methylation, Altered stress resilience |
|- Timepoints||T0 before intervention, T1 immediately after invention, and 6 months monthly follow-up.|
|- Trial web site||www.umcutrecht.nl/hersencentrum/samstudie|
|- CONTACT FOR PUBLIC QUERIES|| Geertje De Lange|
|- CONTACT for SCIENTIFIC QUERIES|| Marco Boks|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|ZonMw, Hersenstichting Nederland|
|- Brief summary||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.|
|- Main changes (audit trail)|
|- RECORD||16-mei-2017 - 11-jun-2017|