DepressionPhase 4REGAINNCT01436643
Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression
A Phase 4 study testing Venlafaxine, Fluoxetine and Citalopram in people with Depression and Relapsing-remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 25 sites in Germany.
Trial summary
This is a prospective, multi-center, open-label study in Relapsing-remitting Multiple Sclerosis (RRMS) patients with mild to moderate depression treated with selected serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI) antidepressants over 16 weeks as add-on to fingolimod… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Relapsing-remitting Multiple Sclerosis
- What is being tested?
- Venlafaxine, Fluoxetine and Citalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 25 sitesGermany
- Study dates
- Nov 2011to Sep 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with relapsing remitting MS defined by 2010 revised McDonald criteria (see Appendix 4)
- Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5 (see Appendix 8)
- Patients with high disease activity despite treatment with a disease modifying therapy (> 1 relapse in the previous year, > 9 hyperintense T2 lesions or > 1 Gd-enhancing lesion or "non-responding" which could be defined as unchanged or increased relapse rate or ongoing severe relapses compared to previous year)or patients with rapidly evolving severe RRMS (e.g. > 2 relapses with disease progression in one year and > 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI)
- Depression according to ICD-10 criteria
- Mild-moderate depression assessed by BDI-II score between 14-28 inclusively measured before study inclusion and before fingolimod is administered
Who cannot join
- Patients with a history of chronic disease of the immune system other than MS which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome. Patients with Crohns disease or ulcerative colitis are excluded without exception
- History or presence of malignancy (other than localized basal or squamous cell carcinoma of the skin)
- Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests
- Negative for varicella-zoster virus IgG antibodies at Screening
- Patients who expect to be treated with any disease modifying drugs (DMD) during the study (i.e. IFN-β, glatiramer acetate); however no washout is needed for DMDs prior to start of fingolimod
- Patients who are or have been treated with:
Show all 14Show fewer
- immunoglobulins and/or monoclonal antibodies (including natalizumab) within 3 months prior to start of fingolimod
- Systemically applied corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to start of fingolimod (nevertheless, topical application is permitted);
- Immunosuppressive medications such as azathioprine or methotrexate, within 3 months prior to start of fingolimod;
- Cyclophosphamid and mitoxantrone within 6 months prior to start of fingolimod
- cladribine at any time
- current psychological or pharmacological treatment for depression (MAO inhibitors in particular), a washout period of 1 month prior start of fingolimod is required
- current treatment with linezolid, a washout period of 1 month prior start of fingolimod is required
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Germany25 sites
Novartis Investigative Site
Achim, 28832
Novartis Investigative Site
Altenholz-Stift, Germany, 24161
Novartis Investigative Site
Aschaffenburg, 63739
Novartis Investigative Site
Bad Honnef, 53604
Novartis Investigative Site
Baesweiler, 52499
Novartis Investigative Site
Berlin, 12621
Novartis Investigative Site
Bielefeld, 33602
Novartis Investigative Site
Bielefeld, 33647
Novartis Investigative Site
Bochum, 44787
Novartis Investigative Site
Bremerhaven, 27574
Novartis Investigative Site
Butzbach, 35510
Novartis Investigative Site
Grevenbroich, 41515
Novartis Investigative Site
Heidenheim, 89518
Novartis Investigative Site
Klingenmünster, 76889
Novartis Investigative Site
Leipzig, 04275
Novartis Investigative Site
Merzig, 66663
Novartis Investigative Site
Nienburg, 31582
Novartis Investigative Site
Oberhausen, 46045
Novartis Investigative Site
Oldenburg, 26122
Novartis Investigative Site
Potsdam, 14471
Novartis Investigative Site
Schwalmstadt-Treysa, 34613
Novartis Investigative Site
Stadtroda, 07646
Novartis Investigative Site
Tübingen, 72076
Novartis Investigative Site
Weil am Rhein, 79576
Novartis Investigative Site
Zwickau, 08060
About this study
Official title: A 21-week, Multicenter, Open Label Study to Evaluate the Safety and Tolerability Profile of the Combination of a SSRI or SNRI Antidepressive Therapy With Oral Fingolimod in the Treatment of RRMS Patients With Mild to Moderate Depression
This is a prospective, multi-center, open-label study in Relapsing-remitting Multiple Sclerosis (RRMS) patients with mild to moderate depression treated with selected serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI) antidepressants over 16 weeks as add-on to fingolimod treatment. It is designed to evaluate the safety and tolerability of this combination in this patient population based on an immunomodulatory treatment with fingolimod.
- Conditions
- Depression, Relapsing-remitting Multiple Sclerosis
- Being tested
- Venlafaxine, Fluoxetine, Citalopram, Fingolimod
- Keywords
- Depression, Multiple Sclerosis, Fingolimod, Venlafaxine, Fluoxetine
- Medical subject headings
- Depression, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenlafaxineDrug
Venlafaxine starting dose was 75 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 150 Mg
FluoxetineDrug
Fluoxetine starting dose was 20 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 40 Mg
CitalopramDrug
Citalopram starting dose was 20 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 40 Mg
FingolimodDrug
Dosage of 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once daily. Fingolimod was supplied in bottles containing 35 capsules each.
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine and Fingolimod | Experimental | Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg Receives: Drug: Fluoxetine; Drug: Fingolimod |
| Venlafaxine and Fingolimod | Experimental | Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg Receives: Drug: Venlafaxine; Drug: Fingolimod |
| Citalopram and Fingolimod | Experimental | Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg Receives: Drug: Citalopram; Drug: Fingolimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death
In this analysis patients with all (serious and non-serious) adverse events, and death were reported.
See Safety Section.
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Due to slow enrollment the study was terminated early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436643
- Sponsor's protocol ID
- CFTY720DDE06
- Other IDs
- 2011-001692-39
- Acronym
- REGAIN
- Status last verified
- Sep 2014
- First submitted
- 16 Sep 2011
- Last updated
- 25 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 21-week, Multicenter, Open Label Study to Evaluate the Safety and Tolerability Profile of the Combination of a SSRI or SNRI Antidepressive Therapy With Oral Fingolimod in the Treatment of RRMS Patients With Mild to Moderate Depression
- ClinicalTrials.gov ID
- NCT01436643
- Acronym / sponsor ID
- REGAIN / CFTY720DDE06
- Conditions
- Depression, Relapsing-remitting Multiple Sclerosis
- Keywords
- Depression, Multiple Sclerosis, Fingolimod, Venlafaxine, Fluoxetine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow enrollment the study was terminated early
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Sep 2011 (estimated)
- Results
- Posted 25 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, open-label study in Relapsing-remitting Multiple Sclerosis (RRMS) patients with mild to moderate depression treated with selected serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI) antidepressants over 16 weeks as add-on to fingolimod treatment. It is designed to evaluate the safety and tolerability of this combination in this patient population based on an immunomodulatory treatment with fingolimod.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine and Fingolimod | Experimental | Drug: Fluoxetine, Drug: FingolimodFingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg |
| Venlafaxine and Fingolimod | Experimental | Drug: Venlafaxine, Drug: FingolimodFingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg |
| Citalopram and Fingolimod | Experimental | Drug: Citalopram, Drug: FingolimodFingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria (see Appendix 4)
- Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5 (see Appendix 8)
- Patients with high disease activity despite treatment with a disease modifying therapy (> 1 relapse in the previous year, > 9 hyperintense T2 lesions or > 1 Gd-enhancing lesion or "non-responding" which could be defined as unchanged or increased relapse rate or ongoing severe relapses compared to previous year)or patients with rapidly evolving severe RRMS (e.g. > 2 relapses with disease progression in one year and > 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI)
- Depression according to ICD-10 criteria
- Mild-moderate depression assessed by BDI-II score between 14-28 inclusively measured before study inclusion and before fingolimod is administered
Key exclusion criteria (14 listed)
- Patients with a history of chronic disease of the immune system other than MS which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome. Patients with Crohns disease or ulcerative colitis are excluded without exception
- History or presence of malignancy (other than localized basal or squamous cell carcinoma of the skin)
- Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests
- Negative for varicella-zoster virus IgG antibodies at Screening
- Patients who expect to be treated with any disease modifying drugs (DMD) during the study (i.e. IFN-β, glatiramer acetate); however no washout is needed for DMDs prior to start of fingolimod
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 |
|---|---|---|
| VenlafaxineVenlafaxine starting dose was 75 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 150 Mg | Drug | Venlafaxine and Fingolimod |
| FluoxetineFluoxetine starting dose was 20 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 40 Mg | Drug | Fluoxetine and Fingolimod |
| CitalopramCitalopram starting dose was 20 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 40 Mg | Drug | Citalopram and Fingolimod |
| FingolimodDosage of 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once daily. Fingolimod was supplied in bottles containing 35 capsules each. | Drug | Citalopram and Fingolimod, Fluoxetine and Fingolimod, Venlafaxine and Fingolimod |
Primary outcome
Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death
Time frame: 21 weeks
In this analysis patients with all (serious and non-serious) adverse events, and death were reported. See Safety Section.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Venlafaxine, Fluoxetine and Citalopram in people with Depression and Relapsing-remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 25 sites in Germany.
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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death (time frame: 21 weeks). 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 25 Sep 2014.