A Phase 4 interventional study of Venlafaxine and Fluoxetine in Depression and Relapsing-remitting Multiple Sclerosis, sponsored by Novartis Pharmaceuticals. Terminated at 25 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-09-25.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 54 is close to the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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
Drug: Fluoxetine · Drug: Fingolimod
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
Drug: Venlafaxine · Drug: Fingolimod
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
Drug: Citalopram · Drug: Fingolimod
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
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
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
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.
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.
Time frame: 21 weeks
The safety set was used for analysis, which consists of 54 patients, of whom 2 patients did not start treatment with any antidepressant
| Milestone | Fluoxetine and Fingolimod | Venlafaxine and Fingolimod | Citalopram and Fingolimod | Pre-treatment With Fingolimod |
|---|---|---|---|---|
| Started | 0 | 0 | 0 | 54 |
| Completed | 0 | 0 | 0 | 44 |
| Not completed | 0 | 0 | 0 | 10 |
| Withdrew: Abnormal test result | 0 | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 5 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 4 |
| Milestone | Fluoxetine and Fingolimod | Venlafaxine and Fingolimod | Citalopram and Fingolimod | Pre-treatment With Fingolimod |
|---|---|---|---|---|
| Started | 17 | 15 | 20 | 0 |
| Completed | 16 | 11 | 17 | 0 |
| Not completed | 1 | 4 | 3 | 0 |
| Withdrew: Adverse event | 0 | 3 | 1 | 0 |
| Withdrew: Abnormal test result | 0 | 0 | 1 | 0 |
| Withdrew: Protocol violation | 1 | 1 | 1 | 0 |
In this analysis patients with all (serious and non-serious) adverse events, and death were reported. See Safety Section.
| Participants | Fluoxetine and Fingolimod | Venlafaxine and Fingolimod | Citalopram and Fingolimod | Fingolimod |
|---|---|---|---|---|
| Any Adverse Event | 11 | 12 | 12 | 15 |
| Death | 0 | 0 | 0 | 0 |
| Serious Adverse Event | 0 | 1 | 1 | 1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fingolimod | — | 1/54 (1.9%) | 15/54 (27.8%) |
| Venlafaxine and Fingolimod | — | 1/15 (6.7%) | 12/15 (80%) |
| Citalopram and Fingolimod | — | 1/20 (5%) | 12/20 (60%) |
| Fluoxetine and Fingolimod | — | 0/17 (0%) | 11/17 (64.7%) |
| Event | Fingolimod | Venlafaxine and Fingolimod | Citalopram and Fingolimod | Fluoxetine and Fingolimod |
|---|---|---|---|---|
| MULTIPLE SCLEROSIS RELAPSENervous system disorders | 0/54 | 1/15 | 0/20 | 0/17 |
| SUICIDAL IDEATIONPsychiatric disorders | 0/54 | 0/15 | 1/20 | 0/17 |
| CEREBRAL HAEMORRHAGENervous system disorders | 1/54 | 0/15 | 0/20 | 0/17 |
| Event | Fingolimod | Venlafaxine and Fingolimod | Citalopram and Fingolimod | Fluoxetine and Fingolimod |
|---|---|---|---|---|
| NAUSEAGastrointestinal disorders | 0/54 | 3/15 | 4/20 | 4/17 |
| MULTIPLE SCLEROSIS RELAPSENervous system disorders | 2/54 | 2/15 | 0/20 | 2/17 |
| INSOMNIAPsychiatric disorders | 1/54 | 2/15 | 0/20 | 0/17 |
| HYPERHIDROSISSkin and subcutaneous tissue disorders | 0/54 | 2/15 | 0/20 | 1/17 |
| FATIGUEGeneral disorders | 0/54 | 1/15 | 0/20 | 2/17 |
| NASOPHARYNGITISInfections and infestations | 2/54 | 1/15 | 1/20 | 2/17 |
| HEADACHENervous system disorders | 1/54 | 1/15 | 1/20 | 2/17 |
| ALOPECIASkin and subcutaneous tissue disorders | 0/54 | 0/15 | 0/20 | 2/17 |
| LYMPHOPENIABlood and lymphatic system disorders | 6/54 | 0/15 | 0/20 | 0/17 |
| TACHYCARDIACardiac disorders | 0/54 | 1/15 | 0/20 | 0/17 |
The safety set was used for analysis, which consists of 54 patients, of whom 2 patients did not start treatment with any antidepressant
| Age, Continuous(Years) | Fluoxetine and Fingolimod | Venlafaxine and Fingolimod | Citalopram and Fingolimod | Total |
|---|---|---|---|---|
| Mean | 44.2 ± 9.22 | 40.0 ± 9.28 | 41.2 ± 10.22 | 41.8 ± 9.87 |
| Sex: Female, Male(Participants) | Fluoxetine and Fingolimod | Venlafaxine and Fingolimod | Citalopram and Fingolimod | Total |
|---|---|---|---|---|
| Female | 15 | 10 | 17 | 42 |
| Male | 2 | 5 | 3 | 10 |
This study is terminated, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals