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

Phase 3

Completed

Conditions: depression in patients with childhood trauma
10027946

Registration Number: NL-OMON55549

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 31

Inclusion Criteria

1. Diagnosis of current depressive episode as defined by DSM-IV-R as determined
by the SCID.
2. Age 18 -65 years.
3. Stable medication use (in the last month and during study, meaning: no
changes in: mood stabilizer, antidepressants and antipsychotics; dosage changes
are allowed).
4. High levels of childhood trauma (as defined by above moderate to severe
cutoff scores for any of the subscales; 13 for emotional abuse, 10 for physical
abuse, 8 for sexual abuse, 15 for emotional neglect, and 10 physical neglect
using the CTQ (Bernstein et al., 2003).
5. About to receive traumatherapy.

Exclusion Criteria

1. Compulsory admission or treatment under Dutch law (BOPZ)
2. Major somatic disorder interfering with treatment or diagnosis
3. Pregnancy or breastfeeding or the intention to get pregnant in the near
future
4. Rapid cycling (4 or more mood episodes in the previous year).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study outcome is the difference in response rates according to<br /><br>Hamilton Depression ratings, between the treatment and placebo group from<br /><br>baseline to 12 week follow up. Response is defined as 50% reduction or more on<br /><br>the HAM-D.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. The treatment group will be compared to the placebo group regarding changes<br /><br>in:<br /><br>1.1 Montgomery-Åsberg Depression Rating Scale scores (measured weekly<br /><br>over the 12 week intervention period and at 6 month follow-up).<br /><br>1.2 Relation between plasma levels of SAMe, genome-wide DNA methylation<br /><br>and KITLG methylation (measured before and after the 12 week intervention).<br /><br>1.3 Inventory of Depressive Symptomatology (IDS) scores and Altman<br /><br>mania scores (monthly over a 6 month follow-up period).<br /><br>1.4 Altered stress resilience (weekly during 12 weeks intervention and<br /><br>monthly during 6 month follow-up) using APL.<br /><br><br /><br><br /><br>2. Measure SAMe plasma and serum levels and validate the DNA methylation<br /><br>changes in separate cell types and whole blood expression for better<br /><br>understanding of their biological relevance of identified methylation marks.</p><br>