Status:
COMPLETED
Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The proposed study is a randomized, placebo-controlled, double-blind trial to evaluate the safety and efficacy of antidepressant combination for the treatment of depression. Depressive disorder is on...
Detailed Description
Background Information Combining antidepressants is a well-established medical procedure for the treatment of therapy refractory depression, that may also be applied successfully under non-refractory...
Eligibility Criteria
Inclusion
- Women and men aged 18-55 years
- Moderate to severe depressive episode according to ICD10-criteria ICD10:F32.1, F32.2, F33.1, F33.2) and MADRS-sum value \>=18 points
Exclusion
- Bipolar affective disorder incl. BD-II.
- Psychiatric or neurologic comorbidity.
- Depression with psychotic symptoms.
- Pregnancy or lactation period.
- Significant cardiovascular or gastrointestinal disease.
- Severe dysfunction of liver (defined according to Child-Pugh-Criteria (\>=Child A)) or kidney (defined according to KDIGO stage I (albuminuria \>=30mg/g).
- Known and proven pharmacoresistance.
- Proven contraindication against MRI (e.g. pacemaker).
- Known incompatibility against one of the substances used.
- Intake of irreversible inhibitors of monoamine oxidase (MAOI, e.g. tranylcypromine) during last 14 days.
- Known phenylketonuria.
- Women with childbearing potential not using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner).
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00150839
Start Date
March 1 2006
End Date
December 1 2009
Last Update
December 14 2020
Active Locations (1)
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1
Department of Psychiatry and Psychotherapy, University Erlangen-Nuremberg
Erlangen, Bavaria, Germany, 91054