Status:
COMPLETED
Study Of 323U66 SR In Major Depressive Disorder
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
This study was designed to evaluate the efficacy and safety in major depressive disorder patients.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Met DSM-IV-TR criteria for major depressive disorder for their current episode for at least 8 weeks prior to screening visit.
- Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
- Must have rating scores as outlined.
- Exclusion criteria:
- Current or past history of seizure disorder or brain injury.
- Current or past history of anorexia or bulimia nervosa.
- History of manic episode.
- Past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder.
- Diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria.
- Pregnant, possibly pregnant or lactating.
- Must not be suicidal.
- Blood pressure of SBP\>160mmHg, DBP\>100mmHg.
- History or complication of cancer or malignant tumour.
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2007
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT00135512
Start Date
December 1 2004
End Date
May 28 2007
Last Update
February 1 2019
Active Locations (7)
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1
GSK Investigational Site
Fukuoka, Japan, 814-0180
2
GSK Investigational Site
Hyōgo, Japan, 651-1145
3
GSK Investigational Site
Kanagawa, Japan, 228-0828
4
GSK Investigational Site
Kumamoto, Japan, 861-8002