Last updated: 11/04/2018 04:34:55

Study Of 323U66 SR In Major Depressive Disorder

GSK study ID
AK1102364
See study documents
Clinicaltrials.gov ID
NCT00135512
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open-Label, Multi-Center, Phase II Study Evaluating the Safety and Efficacy of 323U66 SR in Patients with Depression
Trial description: This study was designed to evaluate the efficacy and safety in major depressive disorder patients.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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:

Change from Baseline in the MADRS total score at Week 52 in observed cases

Timeframe: Baseline (Week 0) and Week 52

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

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

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

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

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

Interventions:
  • Drug: bupropion hydrochloride
    • Enrollment:
    234
    Primary completion date:
    2007-28-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Depressive Disorder
    Product
    bupropion
    Collaborators
    Not applicable
    Study date(s)
    December 2004 to May 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 64 years
    Accepts healthy volunteers
    No
    • 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.
    • Current or past history of seizure disorder or brain injury.
    • Current or past history of anorexia or bulimia nervosa.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Unknown, Japan
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kanagawa, Japan, 228-0828
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kumamoto, Japan, 861-8002
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tokyo, Japan, 160-0023
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hyogo, Japan, 651-1145
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Fukuoka, Japan, 814-0180
    Status
    Study Complete
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    Showing 1 - 6 of 7 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-28-05
    Actual study completion date
    2007-28-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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