SAM study: An epigenetic therapy for depression after childhood trauma

SAMe as an epigenetic treatment of depression in people with bipolar disorder and childhood trauma, a double blind placebo-controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21753

Enrollment

100

Registered

2017-05-16

Start date

2017-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bipolar disorder

Interventions

S-adenosyl-L-methionine 12 weeks, oral, 1200 mg daily, versus placebo

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
50 percent reduction of 50% or more of the Hamilton Depression Rating Scale	—

Secondary

Measure	Time frame
MADRS, genome-wide DNA methylation and KITLG methylation, Altered stress resilience	—

Contacts

Public ContactGeertje De Lange

G.M.deLange@umcutrecht.nl+31 88 755 0695

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)