Depressive DisorderPhase 2NCT00448058
A Study Of New Medicine (GSK 372475) For The Treatment Of Depression
A Phase 2 study testing GSK372475 and venlafaxine in people with Depressive Disorder, run by GlaxoSmithKline at 42 sites in 12 countries.
Trial summary
To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects 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
- What is being tested?
- GSK372475 and venlafaxine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 42 sitesin 12 countries
- Study dates
- Apr 2007to Dec 2008
- 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
- Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR criteria)
- Duration of current episode is at least 12 weeks duration and less than 2 years
- Symptoms of decreased energy, pleasure, and interest
- Female subjects who agree to use acceptable methods of birth control throughout the study
Who cannot join
- Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial
- Symptoms of MDE better accounted for by another diagnosis
- Diagnosis of Bipolar, schizophrenia, other psychotic disorder(s), borderline or antisocial personality disorder, or dementia.
- Started psychotherapy within 3 months prior to the Screening
- Received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening
- Received psychoactive drugs within 4 weeks of randomization
Show all 11Show fewer
- Positive urine drug screen or positive blood alcohol
- Suicidal risk or has had any previous suicide attempt, a family history of suicide attempt
- Positive pregnancy test
- History of seizure disorder, myocardial infarction (< 1yr), or unstable medical condition
- Failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants
Trial locations and contacts
42 sites in 12 countries.
42 sites in 12 countries
Canada7 sites
GSK Investigational Site
Burlington, Ontario, L7R 4E2
GSK Investigational Site
Edmonton, Alberta, T6L 5X8
GSK Investigational Site
Kelowna, British Columbia, V1Y 2H4
GSK Investigational Site
Mississauga, Ontario, L5M 4N4
GSK Investigational Site
Montreal, Quebec, H2T 2N6
GSK Investigational Site
Sydney, Nova Scotia, B1P 1C6
GSK Investigational Site
Sydney, Nova Scotia, B1S 2E8
Germany5 sites
GSK Investigational Site
Munich, Bavaria, 80333
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19053
GSK Investigational Site
Unterhaching, Bavaria, 82008
GSK Investigational Site
Westerstede, Lower Saxony, 26655
GSK Investigational Site
Würzburg, Bavaria, 97070
Australia4 sites
GSK Investigational Site
Auchenflower, Queensland, 4066
GSK Investigational Site
Epping, Victoria, 3076
GSK Investigational Site
Heidelberg West, Victoria, 3081
GSK Investigational Site
Kippa-Ring, Queensland, 4021
India4 sites
GSK Investigational Site
Bangalore, 560010
GSK Investigational Site
Chennai, 600003
GSK Investigational Site
Hyderabad, 500 034
GSK Investigational Site
Tirupati, 517507
Poland4 sites
GSK Investigational Site
Bialystok, 15-879
GSK Investigational Site
Gdansk, 80-282
GSK Investigational Site
Lublin, 20-442
GSK Investigational Site
Skorzewo, 60-185
South Africa4 sites
GSK Investigational Site
Observatory ,Cape Town, 7925
GSK Investigational Site
Somerset West, 7140
GSK Investigational Site
Somerset West, 7500
GSK Investigational Site
Vereeniging, 1929
Estonia3 sites
GSK Investigational Site
Tallinn, 10614
GSK Investigational Site
Tartu, 50417
GSK Investigational Site
Võru, 65620
France3 sites
GSK Investigational Site
Arcachon, 33120
GSK Investigational Site
Paris, 75012
GSK Investigational Site
Toulouse, 31000
Belgium2 sites
GSK Investigational Site
Liège, 4000
GSK Investigational Site
Mont-Godinne, 5530
Bulgaria2 sites
GSK Investigational Site
Burgas, 8000
GSK Investigational Site
Varna, 9010
Finland2 sites
GSK Investigational Site
Kuopio, 70110
GSK Investigational Site
Turku, 20100
Slovakia2 sites
GSK Investigational Site
Bratislava, 826 06
GSK Investigational Site
Michalovce, 071 01
About this study
Official title: A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/Day to 2.0 mg/Day) or Extended Release Venlafaxine XR (150 mg/Day to 225 mg/Day) Compared to Placebo in Adult s
To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)
Read the detailed description
A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/day to 2.0 mg/day) or Extended Release Venlafaxine XR (150 mg/day to 225 mg/day) Compared to Placebo in Adult Subjects Diagnosed with Major Depressive Disorder
- Conditions
- Depressive Disorder
- Being tested
- GSK372475, venlafaxine, placebo
- Keywords
- Flexible-dose, GSK372475, MDD, Venlafaxine XR, Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK372475Drug
daily administration during the 10-week treatment phase
venlafaxineDrug
daily administration during the 10-week treatment phase
placeboDrug
daily administration during the 10-week treatment phase
| Study group | Role | What they receive |
|---|---|---|
| GSK372475 | Experimental | flexible-dose design from GSK372475 1.0 mg/day to GSK372475 2.0 mg/day Receives: Drug: GSK372475 |
| Venlafaxine | Active comparator | Flexible- dose design from Venlafaxine XR 75 mg/day to Venlafaxine XR 225 mg/day Receives: Drug: venlafaxine |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale.
Measured: Randomisation (week 0) And end of the treatment
Secondary outcomes (1)
Endpoints related to response & remission on depression rating scales during time of treatment exposureChange during treatment & at endpoint-week 10:in Clinical Global Impression scale; in motivation, energy, & sexual functioning on patient-rated scales
Measured: Randomisation (week 0) and at weeks 1,2,4,6,8 and week 10 (end of treatment phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionDec 2008
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 DisorderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 396 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
- NCT00448058
- Sponsor's protocol ID
- SND 103285
- Status last verified
- Nov 2011
- First submitted
- 13 Mar 2007
- Last updated
- 10 Oct 2014
- Results posted
- No
Publications
Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell JG, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Efficacy, safety, and tolerability of a triple reuptake inhibitor GSK372475 in the treatment of patients with major depressive disorder: two randomized, placebo- and active-controlled clinical trials. J Psychopharmacol. 2012 May;26(5):653-62. doi: 10.1177/0269881111424931. Epub 2011 Nov 2.
PubMed 22048884
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/Day to 2.0 mg/Day) or Extended Release Venlafaxine XR (150 mg/Day to 225 mg/Day) Compared to Placebo in Adult s
- ClinicalTrials.gov ID
- NCT00448058
- Acronym / sponsor ID
- SND 103285
- Conditions
- Depressive Disorder
- Keywords
- Flexible-dose, GSK372475, MDD, Venlafaxine XR, Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 15 Mar 2007 (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.
To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)
Detailed description
A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/day to 2.0 mg/day) or Extended Release Venlafaxine XR (150 mg/day to 225 mg/day) Compared to Placebo in Adult Subjects Diagnosed with Major Depressive Disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GSK372475 | Experimental | Drug: GSK372475flexible-dose design from GSK372475 1.0 mg/day to GSK372475 2.0 mg/day |
| Venlafaxine | Active comparator | Drug: venlafaxineFlexible- dose design from Venlafaxine XR 75 mg/day to Venlafaxine XR 225 mg/day |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR criteria)
- Duration of current episode is at least 12 weeks duration and less than 2 years
- Symptoms of decreased energy, pleasure, and interest
- Female subjects who agree to use acceptable methods of birth control throughout the study
Key exclusion criteria (11 listed)
- Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial
- Symptoms of MDE better accounted for by another diagnosis
- Diagnosis of Bipolar, schizophrenia, other psychotic disorder(s), borderline or antisocial personality disorder, or dementia.
- Started psychotherapy within 3 months prior to the Screening
- Received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening
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 |
|---|---|---|
| GSK372475daily administration during the 10-week treatment phase | Drug | GSK372475 |
| venlafaxinedaily administration during the 10-week treatment phase | Drug | Venlafaxine |
| placebodaily administration during the 10-week treatment phase | Drug | placebo |
Primary outcome
Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale.
Time frame: Randomisation (week 0) And end of the treatment
1 secondary outcome
Endpoints related to response & remission on depression rating scales during time of treatment exposureChange during treatment & at endpoint-week 10:in Clinical Global Impression scale; in motivation, energy, & sexual functioning on patient-rated scales
Time frame: Randomisation (week 0) and at weeks 1,2,4,6,8 and week 10 (end of treatment phase)
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 10 Oct 2014.
- Background: PubMed 22048884Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell JG, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Efficacy, safety, and tolerability of a triple reuptake inhibitor GSK372475 in the treatment of patients with major depressive disorder: two randomized, placebo- and active-controlled clinical trials. J Psychopharmacol. 2012 May;26(5):653-62. doi: 10.1177/0269881111424931. Epub 2011 Nov 2.
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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
42 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK372475 and venlafaxine in people with Depressive Disorder, run by GlaxoSmithKline at 42 sites in 12 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 4 inclusion and 11 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 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Canada, Germany, Australia, India, Poland and 7 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. Some participants in this study may receive a placebo. 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 from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale. (time frame: Randomisation (week 0) And end of the 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 NCT00448058, 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 10 Oct 2014.