Major Depressive disorder MedDRA version: 16.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Major depressive disorder with current major de-pressive episode according to a SCID-I/P interview Montgomery-Åsberg depression rating score 15-30 Age 18-60 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
Exclusion criteria: -Borderline, schizoid or schizotypal personality disorder -Bipolar disorder -Any psychotic disorder -Primary diagnosis is anxiety disorder: 300.01, 300.21, 300.22, 300.29, 300.23, 300.3, 309.81, 308.3, 300.02, 293.89, 300.00 -Significant current suicidal ideation, or history of a suicide attempt -Lifetime substance dependence; Last-year substance abuse; Last month over 24/16 standard doses of alcohol/week; Lifetime use of illicit substances >x5; any illicit substance use in last month; other clinical reason to suspect substance use disorder -Depressive disorder due to medical condition or chemical substance -Antidepressant medication use in last 4 months -Severe, unstable somatic illness -Use of; antipsychotics, mood stabilizers, systemic corticosteroids, ß-blockers or daytime benzodiazepines (a small dose of =10mg zolpidem once daily is permissible)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the causal sequence of change during antidepressant medication.;Secondary Objective: To develop efficacy markers for antidepressant interventions.;Primary end point(s): Change in symptom scale scores (BDI, BAI, MADRS). | — |
Countries
Finland