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Completed

NCT Number: NCT00048204

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

A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)

Completed

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Key information

Conditions

Depressive Disorder, Major Behavior Behavioral Symptoms Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW597599B

Drug

paroxetine

Drug

Other names: GW597599B

Primary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: 8 Weeks

Secondary outcomes

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

    Time frame: 8 Weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Oct 30, 2002
Registry last updated
Oct 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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