Chronos: Can the antidepressive response induced by sleep deprivation (wake-therapy) be sustained through continuous stabilisation of the diurnal rhythm and long term light treatment in patients with major depression treated with duloxetine? - Chronos
Phase 1
- Conditions
- Major depression
- Registration Number
- EUCTR2005-001855-39-DK
- Lead Sponsor
- Psychiatric Research Unit, Frederiksborg General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>Compliance of drug less than 85%<br>Compliance with visits less than 85%<br>Eligibility violations <br>Severe adverse events
- Secondary Outcome Measures
Name Time Method