Major depression
Conditions
Interventions
Trade Name: Cymbalta
Product Name: Duloxetine
Pharmaceutical Form: Capsule, soft
Sponsors
Psychiatric Research Unit, Frederiksborg General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A diagnosis of major depression according to DSM-IV Age of 18 or above A score on the Hamilton Depression Scale,17 items version of at least 18 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: Primary psychotic disorder Psychotic depression Drug or alcohol abuse Severe organic brain disease Severe suicidal ideation (a score of 2 or above on the Hamilton Depression Scale, 17-items version) Mental retardation Pregnancy or lactation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the present study is to examine whether the combination of duloxetine and chronoterapeutic methods induces higher remission and response rates at an earlier time point.;Secondary Objective: ;Primary end point(s): Study completed (29 weeks) Compliance of drug less than 85% Compliance with visits less than 85% Eligibility violations Severe adverse events | — |
Countries
Denmark
Outcome results
None listed