Depressive Disorder, MajorPhase 2NCT00413023
Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)
A Phase 2 study testing GW679769 in people with Depressive Disorder, Major, run by GlaxoSmithKline at 39 sites in 11 countries.
Trial summary
The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- GW679769
- How many people
- 348 participants
- Where
- 39 sitesin 11 countries
- Study dates
- Jun 2005to Sep 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
39 sites in 11 countries.
39 sites in 11 countries
Germany9 sites
GSK Investigational Site
Achim, Lower Saxony, 28832
GSK Investigational Site
Berlin, State of Berlin, 10629
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44869
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44892
GSK Investigational Site
Dresden, Saxony, 01097
GSK Investigational Site
Ellwangen, Baden-Wurttemberg, 73479
GSK Investigational Site
Hattingen, North Rhine-Westphalia, 45525
GSK Investigational Site
Hüttenberg, Hesse, 35625
GSK Investigational Site
Würzburg, Bavaria, 97070
Slovakia6 sites
GSK Investigational Site
Bratislava, 813 69
GSK Investigational Site
Bratislava, 826 06
GSK Investigational Site
Levoča, 054 01
GSK Investigational Site
Liptovský Mikuláš, 031 23
GSK Investigational Site
Rimavská Sobota, 979 12
GSK Investigational Site
Trenčín, 911 01
Argentina4 sites
GSK Investigational Site
Buenos Aires, Buenos Aires, C1122AAN
GSK Investigational Site
Buenos Aires, C1062ABF
GSK Investigational Site
Buenos Aires, C1425BPK
GSK Investigational Site
Córdoba, Córdoba Province, 5000
Belgium4 sites
GSK Investigational Site
Alken, 3570
GSK Investigational Site
Kortrijk, 8500
GSK Investigational Site
Liège, 4000
GSK Investigational Site
Mont-Godinne, 5530
Chile4 sites
GSK Investigational Site
Providencia / Santiago, Región Metro de Santiago, 7500710
GSK Investigational Site
Santiago, Región Metro de Santiago, 7510186
GSK Investigational Site
Santiago, Región Metro de Santiago, 7580208
GSK Investigational Site
Santiago, Región Metro de Santiago
Italy4 sites
GSK Investigational Site
Bologna, Emilia-Romagna, 40136
GSK Investigational Site
Guardiagrele (CH), Abruzzo, 66016
GSK Investigational Site
Milan, Lombardy, 20127
GSK Investigational Site
Pisa, Tuscany, 56126
Poland3 sites
GSK Investigational Site
Bialystok, 15-879
GSK Investigational Site
Chełmno, 86-200
GSK Investigational Site
Kościan, 64-000
Costa Rica2 sites
GSK Investigational Site
San José, Provincia de San José
GSK Investigational Site
San José
About this study
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)
The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD).
- Conditions
- Depressive Disorder, Major
- Being tested
- GW679769
- Keywords
- depression, major depressive disorder, MDD
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW679769Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on a Depression rating scale following 8 weeks of treatment.
Secondary outcomes (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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startJun 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413023
- Sponsor's protocol ID
- NKF100096
- Status last verified
- Oct 2016
- First submitted
- 24 Aug 2005
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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.
PubMed 22020354
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00413023
- Acronym / sponsor ID
- NKF100096
- Conditions
- Depressive Disorder, Major
- Keywords
- depression, major depressive disorder, MDD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 19 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW679769 | Drug | – |
Primary outcome
Change in score on a Depression rating scale following 8 weeks of treatment.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Background: PubMed 22020354Ratti 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
39 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW679769 in people with Depressive Disorder, Major, run by GlaxoSmithKline at 39 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Germany, Slovakia, Argentina, Belgium, Chile and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score on a Depression rating scale following 8 weeks of treatment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00413023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.