Hippocampal volume in young adults with moderate to severe depression before and after combined antidepressant therapy - C.O.A.T.S
- Conditions
- moderate to severe depression (episodes and recurrent diseases)
- Registration Number
- EUCTR2004-002788-25-DE
- Lead Sponsor
- Department of Psychiatry and Psychotherapy, University of Erlangen-Nuremberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Men and women aging 18-65 years
moderate to severe depressive illness (according to ICD10 criteria) and 18 or more points in the Montgomery-Asberg-depression rating scale (MADR-S)
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
bipolar affective disorder
psychiatric or neurologic comorbidity
psychotic depression
pregnancy, lactation
significant cardiovascular or gastrointestinal disease
severe disorder of liver or kidney function
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate, whether the combination of Remergil with another antidepressant (Trevilor ret.) is more effective in reducing depressive symptomatology than is Remergil alone.;Secondary Objective: To evaluate, whether the antidepressant effect starts earlier in combination vs. monotherapy. to evaluate, if side effects occur more or less often during combination vs. monotherapy.;Primary end point(s): Categorical response to treatment. Categorical response is defined on the CGI scale and 50% reduction in the MADR-S sum score.
- Secondary Outcome Measures
Name Time Method