Last updated: 11/04/2018 09:40:31

A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder

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GSK study ID
NKD20006
See study documents
Clinicaltrials.gov ID
NCT00048204
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 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Fixed-Dose Study Comparing the Efficacy and Safety of GW597599B or Paroxetine to Placebo in Moderately to Severely Depressed Patients with Major Depressive Disorder
Trial description: A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Hamilton Depression Rating Scale

Timeframe: 8 Weeks

Secondary outcomes:

Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale

Timeframe: 8 Weeks

Interventions:
  • Drug: GW597599B
  • Drug: paroxetine
    • Enrollment:
    372
    Primary completion date:
    2003-30-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Depressive Disorder, Major
    Product
    vestipitant
    Collaborators
    Not applicable
    Study date(s)
    November 2002 to September 2003
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Patients meet the diagnosis of Major Depressive Disorder (MDD).
    • Patients with a primary diagnosis other than MDD.
    • Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients meet the diagnosis of Major Depressive Disorder (MDD).
    Exclusion criteria:
    • Patients with a primary diagnosis other than MDD.
    • Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder.
    • Patients receiving formal psychotherapy or cognitive/behavioral therapy concurrently or in the 12 weeks prior to screening visit.
    • Patient is actively suicidal.
    • Patients who have a history of migraine headaches.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2003-30-09
    Actual study completion date
    2003-30-09

    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

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