Depressive Disorder, MajorPhase 2NCT00636246
A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.
A Phase 2 study testing sertraline/[S,S]-reboxetine, sertraline and [S,S]-reboxetine monotherapy in people with Depressive Disorder, Major, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 17 sites in 2 countries.
Trial summary
This study was designed to determine if the novel combination of the SSRI, sertraline, and the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable safety profile of SSRIs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- sertraline/[S,S]-reboxetine, sertraline and [S,S]-reboxetine monotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Jun 2004to Aug 2005
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must fulfill the criteria for MDD without psychotic features as defined by DSMIV, based on clinical assessment and confirmed by Structural Clinical Interview for DSM-IV Axis I Disorder-Clinical Version (SCID-I) plus the MDD Specifiers included in the Research Version of SCID-I.
- HAM-D (17-item) ≥ 22 at Screening (Visit 1) and > 20 at Baseline (Visit 2).
- Minimum CGI-S ≥ 4 at Screening (Visit 1) and at Baseline (Visit 2).
Who cannot join
- Known failure to satisfactory respond after adequate dose and duration (12 weeks) of treatment with clomipramine and one SSRI, or with two or more SSRIs.
- Subjects with > 20% HAM-D (17-item) improvement (decrease) from Screening (Visit 1) at Baseline (Visit 2).
- Subjects with uncorrected hypothyroidism or hyperthyroidism.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Russia13 sites
Pfizer Investigational Site
Kazan', 420012
Pfizer Investigational Site
Moscow, 107076
Pfizer Investigational Site
Moscow, 115522
Pfizer Investigational Site
Moscow, 119034
Pfizer Investigational Site
Moscow, 127473
Pfizer Investigational Site
Moscow
Pfizer Investigational Site
Rostov-on-Don, 344010
Pfizer Investigational Site
Saint Petersburg, 190121
Pfizer Investigational Site
Saint Petersburg, 192019
Pfizer Investigational Site
Saint Petersburg, 193167
Pfizer Investigational Site
Saint Petersburg, 194214
Pfizer Investigational Site
Smolensk, 214019
Pfizer Investigational Site
Tomsk, 634014
Estonia4 sites
Pfizer Investigational Site
Pärnu, 80012
Pfizer Investigational Site
Tallinn, 10614
Pfizer Investigational Site
Tartu, 51008
Pfizer Investigational Site
Viljandi, Viljandi Mk., 71024
About this study
Official title: Sertraline/[S,S]-Reboxetine Combination Versus Sertraline And [S,S]-Reboxetine Monotherapy In Major Depressive Disorder (MDD) In A Double-Blind, Placebo-Controlled, Eight Week Study.
This study was designed to determine if the novel combination of the SSRI, sertraline, and the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable safety profile of SSRIs.
- Conditions
- Depressive Disorder, Major
- Being tested
- sertraline/[S,S]-reboxetine, sertraline, Placebo, [S,S]-reboxetine monotherapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertraline/[S,S]-reboxetineDrug
Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg [S,S]-reboxetine for 5 and one half weeks.
sertraline/[S,S]-reboxetineDrug
Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/6mg [S,S]-reboxetine for 5 and one half weeks.
sertralineDrug
Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks.
sertralineDrug
Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks
sertraline/[S,S]-reboxetineDrug
Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks.
PlaceboDrug
Tablets, orally once per day for 8 weeks
sertraline/[S,S]-reboxetineDrug
Tablets, 50mg sertraline/2mg [S,S]-reboxetine orally for 3 days, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks
[S,S]-reboxetine monotherapyDrug
Tablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sertraline/[S,S]-Reboxetine-satellite150/4 | Experimental | Not described Receives: Drug: sertraline/[S,S]-reboxetine |
| Sertraline/[S,S]-Reboxetine-satellite150/6 | Experimental | Not described Receives: Drug: sertraline/[S,S]-reboxetine |
| sertraline-satellite | Active comparator | Not described Receives: Drug: sertraline |
| sertraline-main | Active comparator | Not described Receives: Drug: sertraline |
| Sertraline/[S,S]-Reboxetine-satellite150/2 | Experimental | Not described Receives: Drug: sertraline/[S,S]-reboxetine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Sertraline/[S,S]-Reboxetine-main | Experimental | Not described Receives: Drug: sertraline/[S,S]-reboxetine |
| [S,S]-reboxetine-main | Active comparator | Not described Receives: Drug: [S,S]-reboxetine monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from Baseline up to Week 8 (Visit 9) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as measured by a mixed concentration, suicidal ideation and restlessness.
Measured: visits 1-9
Secondary outcomes (4)
Change from Baseline in HAM-D (17-item) total score
Measured: Weeks 1, 2, 3, 5, 6, and 8
Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES)
Measured: Weeks 5 and 8
The frequency and severity of treatment-emergent adverse events, ECG changes, laboratory and vital signs changes by treatment group using descriptive statistics.
Measured: Weeks 1, 2, 3, 5, 6, and 8
Change from Baseline in MADRS total score
Measured: Weeks 1, 2, 3, 5, 6, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startJun 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636246
- Sponsor's protocol ID
- A0501075
- Status last verified
- Jan 2021
- First submitted
- 7 Mar 2008
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sertraline/[S,S]-Reboxetine Combination Versus Sertraline And [S,S]-Reboxetine Monotherapy In Major Depressive Disorder (MDD) In A Double-Blind, Placebo-Controlled, Eight Week Study.
- ClinicalTrials.gov ID
- NCT00636246
- Acronym / sponsor ID
- A0501075
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Aug 2005 (actual)
- First posted
- 14 Mar 2008 (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.
This study was designed to determine if the novel combination of the SSRI, sertraline, and the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable safety profile of SSRIs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sertraline/[S,S]-Reboxetine-satellite150/4 | Experimental | Drug: sertraline/[S,S]-reboxetine |
| Sertraline/[S,S]-Reboxetine-satellite150/6 | Experimental | Drug: sertraline/[S,S]-reboxetine |
| sertraline-satellite | Active comparator | Drug: sertraline |
| sertraline-main | Active comparator | Drug: sertraline |
| Sertraline/[S,S]-Reboxetine-satellite150/2 | Experimental | Drug: sertraline/[S,S]-reboxetine |
| Placebo | Placebo comparator | Drug: Placebo |
| Sertraline/[S,S]-Reboxetine-main | Experimental | Drug: sertraline/[S,S]-reboxetine |
| [S,S]-reboxetine-main | Active comparator | Drug: [S,S]-reboxetine monotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must fulfill the criteria for MDD without psychotic features as defined by DSMIV, based on clinical assessment and confirmed by Structural Clinical Interview for DSM-IV Axis I Disorder-Clinical Version (SCID-I) plus the MDD Specifiers included in the Research Version of SCID-I.
- HAM-D (17-item) ≥ 22 at Screening (Visit 1) and > 20 at Baseline (Visit 2).
- Minimum CGI-S ≥ 4 at Screening (Visit 1) and at Baseline (Visit 2).
Key exclusion criteria (3 listed)
- Known failure to satisfactory respond after adequate dose and duration (12 weeks) of treatment with clomipramine and one SSRI, or with two or more SSRIs.
- Subjects with > 20% HAM-D (17-item) improvement (decrease) from Screening (Visit 1) at Baseline (Visit 2).
- Subjects with uncorrected hypothyroidism or hyperthyroidism.
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 |
|---|---|---|
| sertraline/[S,S]-reboxetineTablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg [S,S]-reboxetine for 5 and one half weeks. | Drug | Sertraline/[S,S]-Reboxetine-satellite150/4 |
| sertraline/[S,S]-reboxetineTablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/6mg [S,S]-reboxetine for 5 and one half weeks. | Drug | Sertraline/[S,S]-Reboxetine-satellite150/6 |
| sertralineTablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks. | Drug | sertraline-satellite |
| sertralineTablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks | Drug | sertraline-main |
| sertraline/[S,S]-reboxetineTablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks. | Drug | Sertraline/[S,S]-Reboxetine-satellite150/2 |
| PlaceboTablets, orally once per day for 8 weeks | Drug | Placebo |
| sertraline/[S,S]-reboxetineTablets, 50mg sertraline/2mg [S,S]-reboxetine orally for 3 days, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks | Drug | Sertraline/[S,S]-Reboxetine-main |
| [S,S]-reboxetine monotherapyTablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks | Drug | [S,S]-reboxetine-main |
Primary outcome
The change from Baseline up to Week 8 (Visit 9) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as measured by a mixed concentration, suicidal ideation and restlessness.
Time frame: visits 1-9
4 secondary outcomes
Change from Baseline in HAM-D (17-item) total score
Time frame: Weeks 1, 2, 3, 5, 6, and 8
Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES)
Time frame: Weeks 5 and 8
The frequency and severity of treatment-emergent adverse events, ECG changes, laboratory and vital signs changes by treatment group using descriptive statistics.
Time frame: Weeks 1, 2, 3, 5, 6, and 8
Change from Baseline in MADRS total score
Time frame: Weeks 1, 2, 3, 5, 6, and 8
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 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sertraline/[S,S]-reboxetine, sertraline and [S,S]-reboxetine monotherapy in people with Depressive Disorder, Major, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 17 sites in 2 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 3 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 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Russia, Estonia. 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?
The change from Baseline up to Week 8 (Visit 9) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as measured by a mixed concentration, suicidal ideation and restlessness. (time frame: visits 1-9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2021.