Study Of 323U66 SR In Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00135512
First received: August 24, 2005
Last updated: August 1, 2013
Last verified: July 2013

August 24, 2005
August 1, 2013
December 2004
May 2007   (final data collection date for primary outcome measure)
Change from baseline in the MADRS(Montgomery-Asberg Depression Rating Scale) total score. [ Time Frame: 8 Weeks ]
Change from baseline in the MADRS(Montgomery-Asberg Depression Rating Scale) total score
Complete list of historical versions of study NCT00135512 on ClinicalTrials.gov Archive Site
- Change from baseline in the HAM-D total score - Percentage of subjects who are CGI Global Improvement responders - Change from baseline in the SDS total score and the MEI-SF total score [ Time Frame: 8 Weeks ]
- Change from baseline in the HAM-D total score - Percentage of subjects who are CGI Global Improvement responders - Change from baseline in the SDS total score and the MEI-SF total score
Not Provided
Not Provided
 
Study Of 323U66 SR In Major Depressive Disorder
Clinical Evaluation of 323U66 SR in Patients With Depression - Open-Label Study -

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depressive Disorder
Drug: bupropion hydrochloride
Study drug
Other Name: bupropion hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2007
May 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Spain
 
NCT00135512
AK1102364
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP