Last updated: 11/04/2018 09:41:37
Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GW679769
Enrollment:
348
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical 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 Two Double-Blind, Placebo-Controlled Studies of the Novel NK1 Receptor Antagonist Casopitant in Patients with Major Depressive Disorder . [J Clin Psychopharmacol]. 2011;31(6):727-733.
Medical condition
Depressive Disorder, Major
Product
casopitant, paroxetine
Collaborators
Not applicable
Study date(s)
June 2005 to September 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
No
- Primary diagnosis of Major depressive Disorder as defined in DSM-IV.
- Capable of giving informed consent and willing to comply with the study requirements.
- 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.
Inclusion and exclusion 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).
Trial location(s)
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1425BPK
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7510186
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44892
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1122AAN
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44869
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hattingen, Nordrhein-Westfalen, Germany, 45525
Status
Study Complete
Location
GSK Investigational Site
Guardiagrele (CH), Abruzzo, Italy, 66016
Status
Study Complete
Location
GSK Investigational Site
Ellwangen, Baden-Wuerttemberg, Germany, 73479
Status
Study Complete
Location
GSK Investigational Site
Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1062ABF
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
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
Not applicable
Actual study completion date
Not applicable
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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Additional information
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