Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)
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ClinicalTrials.gov Identifier: NCT00413023 |
Recruitment Status
:
Completed
First Posted
: December 19, 2006
Last Update Posted
: October 28, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depressive Disorder, Major | Drug: GW679769 | Phase 2 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413023

Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Study Protocol

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

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

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

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

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

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

For additional information about this study please refer to the GSK Clinical Study Register
Publications:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00413023 History of Changes |
Other Study ID Numbers: |
NKF100096 |
First Posted: | December 19, 2006 Key Record Dates |
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 |