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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2003-30-09
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)

No location data available.

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
Completed
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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