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

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048204
• Other study ID #: NKD20006
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2002
• Last updated: October 5, 2017
• Start date: November 4, 2002
• Est. completion date: September 30, 2003

Study information

• Verified date: October 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: September 30, 2003
• Est. primary completion date: September 30, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

Drug:
• GW597599B

• paroxetine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale		8 Weeks
Secondary	Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale		8 Weeks

External Links

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