Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD).

Condition or disease	Intervention/treatment	Phase
Depressive Disorder, Major	Drug: GW679769	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	348 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects With Major Depressive Disorder (MDD)
Study Start Date :	June 2005
Actual Primary Completion Date :	September 2006
Actual Study Completion Date :	September 2006

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change in score on a Depression rating scale following 8 weeks of treatment.

Secondary Outcome Measures :

1. Change in score on a number of rating scales following 8 weeks of treatment assessing symptomatic, behavioural and functional parameters which together provide a more complete description of the disorder.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 64 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

• Primary diagnosis of Major depressive Disorder as defined in DSM-IV.
• Capable of giving informed consent and willing to comply with the study requirements.
• Women of childbearing potential must agree to one of a number of defined acceptable methods of birth control.

Exclusion Criteria:

• Primary diagnosis within the past 6 months of another Axis 1 disorder such as an anxiety disorder.
• Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type.
• Subjects who, in the investigator's judgement, pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
• Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine).
• Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG).

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 38 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Study Protocol 

Identifier: NKF100096
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: NKF100096
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: NKF100096
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: NKF100096
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: NKF100096
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: NKF100096
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: NKF100096
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

Ratti E, Bellew K, Bettica P, Bryson H, Zamuner S, Archer G, Squassante L, Bye A, Trist D, Krishnan KR, Fernandes S. Results from 2 randomized, double-blind, placebo-controlled studies of the novel NK1 receptor antagonist casopitant in patients with major depressive disorder. J Clin Psychopharmacol. 2011 Dec;31(6):727-33. doi: 10.1097/JCP.0b013e31823608ca. Erratum in: J Clin Psychopharmacol. 2012 Apr;32(2):185.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00413023 History of Changes
Other Study ID Numbers:	NKF100096
First Posted:	December 19, 2006
Last Update Posted:	October 28, 2016
Last Verified:	October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

depression; major depressive disorder; MDD

Additional relevant MeSH terms:

Disease; Depressive Disorder; Depression; Depressive Disorder, Major; Pathologic Processes; Mood Disorders; Mental Disorders; Behavioral Symptoms; Casopitant	Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Neurokinin-1 Receptor Antagonists; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action