Depressive episode in people with childhood trauma
Conditions
Interventions
Product Name: S-Adenosylmethionine
Pharmaceutical Form: Tablet
INN or Proposed INN: ADEMETIONINE
CAS Number: 29908-03-0
Concentration unit: IU/mg international unit(s)/milligram
Concentration type: e
Sponsors
University Medical Centre Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
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 6 months). 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 or for physical abuse, 8 for sexual abuse, 15 for emotional neglect, and 10 physical neglect using the CTQ (Bernstein et al., 2003). 5. Suitable for trauma therapy. 6. Capable of providing written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Compulsory admission or treatment under Dutch law (BOPZ) 2. Major somatic disorder interfering with treatment or diagnosis 3. Pregnancy or breastfeeding 4. Rapid cycling bipolar disorder (4 or more mood episodes in the previous 12 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare changes in depression ratings in patients with a history of childhood trauma receiving SAMe with patients receiving a placebo over a 12 week follow-up period. ;Secondary Objective: 1. Changes in a DNA methylation mark of childhood trauma (KITLG methylation)- comparison between the two arms 2. Genome-wide methylation changes- comparison between the two arms 3. Altered stress resilience - comparison between the two arms 4. Long term improvement in depression (6 months) - comparison between the two arms;Primary end point(s): Response is defined as 50% reduction of 50% or more of the Hamilton Depression scale. ;Timepoint(s) of evaluation of this end point: t1: immediately after the 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Changes in a DNA methylation mark of childhood trauma (KITLG methylation) 2. Genome-wide methylation 3. Stress resilience 4. Long term depression (6 months);Timepoint(s) of evaluation of this end point: 1. immediately after the 12 weeks of treatment 2. immediately after the 12 weeks of treatment 3. immediately after the 12 weeks of treatment and six months later 4. six months after end of treatment | — |
Countries
Netherlands
Contacts
Public ContactProject coordinator
University Medical Centre Utrecht
Outcome results
None listed