Clinical trial NCT00135512: Study Of 323U66 SR In Major Depressive Disorder
Official title: An Open-Label, Multi-Center, Phase II Study Evaluating the Safety and Efficacy of 323U66 SR in Patients With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder
Keywords: MDD
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-08-26
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the efficacy and safety in major depressive disorder patients.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 in Observed Cases
timeFrame: Baseline (Week 0) and Week 8
Secondary outcomes:
measure: Change From Baseline in the MADRS Total Score at Week 52 in Observed Cases
timeFrame: Baseline (Week 0) and Week 52
measure: Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Weeks 8 and 52 in Observed Cases
timeFrame: Baseline (Week 0) and Week 8, 52
measure: Percentage of Participants Who Were Clinical Global Impression Global Improvement (CGI-I) Responders at Weeks 8 and 52 in Observed Cases
timeFrame: Week 8, 52
measure: Change From Baseline in CGI Severity of Illness (CGI-SI) at Weeks 8 and 52 in Observed Cases
timeFrame: Baseline (Week 0) and Week 8, 52
measure: Change From Baseline in the Sheehan Disability Scale (SDISS) Total Score at Weeks 8 and 52 in Observed Cases
timeFrame: Baseline (Week 0) and Week 8, 52
measure: Change From Baseline in the Motivation Energy Inventory Short Form (MEI-SF) Total Score at Weeks 8 and 52 in Observed Cases
timeFrame: Baseline (Week 0) and Week 8, 52
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Hyogo
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kumamoto
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: