No registrations found.
ID
Source
Brief title
Health condition
bipolar disorder; depression; DNA methylation; childhood trauma; SAMe; S-adenosyl-L-methionine; epigenetic
Sponsors and support
Intervention
Outcome measures
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
Background 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.
Study objective
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
Study design
T0 before intervention, T1 immediately after invention, and 6 months monthly follow-up.
Intervention
S-adenosyl-L-methionine 12 weeks, oral, 1200 mg daily, versus placebo
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6147 |
| NTR-old | NTR6302 |
| Other | ABR : 62020 |