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Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression (REGAIN)

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ClinicalTrials.gov Identifier: NCT01436643
Recruitment Status : Terminated (Due to slow enrollment the study was terminated early)
First Posted : September 20, 2011
Results First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Depression
Relapsing-remitting Multiple Sclerosis
Interventions Drug: Venlafaxine
Drug: Fluoxetine
Drug: Citalopram
Drug: Fingolimod
Enrollment 54
Recruitment Details The safety set was used for analysis, which consists of 54 patients, of whom 2 patients did not start treatment with any antidepressant
Pre-assignment Details  
Arm/Group Title Fluoxetine and Fingolimod Venlafaxine and Fingolimod Citalopram and Fingolimod Pre-treatment With Fingolimod
Hide Arm/Group Description 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 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 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 During 2weeks pre-treatment period patients received Fingolimod 0.5 mg per capsule (hard gelatin capsules) orally once daily.
Period Title: 2-week Pre-treatment
Started 0 0 0 54
Completed 0 0 0 44
Not Completed 0 0 0 10
Reason Not Completed
Abnormal test result             0             0             0             1
Adverse Event             0             0             0             5
Protocol Violation             0             0             0             4
Period Title: Core Phase (16 Weeks)
Started 17 15 20 0
Completed 16 11 17 0
Not Completed 1 4 3 0
Reason Not Completed
Adverse Event             0             3             1             0
Abnormal Test result             0             0             1             0
Protocol Violation             1             1             1             0
Arm/Group Title Fluoxetine and Fingolimod Venlafaxine and Fingolimod Citalopram and Fingolimod Total
Hide Arm/Group Description 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 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 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 Total of all reporting groups
Overall Number of Baseline Participants 17 15 20 52
Hide Baseline Analysis Population Description
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  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 15 participants 20 participants 52 participants
44.2  (9.22) 40.0  (9.28) 41.2  (10.22) 41.8  (9.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 15 participants 20 participants 52 participants
Female
15
  88.2%
10
  66.7%
17
  85.0%
42
  80.8%
Male
2
  11.8%
5
  33.3%
3
  15.0%
10
  19.2%
1.Primary Outcome
Title Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death
Hide Description

In this analysis patients with all (serious and non-serious) adverse events, and death were reported.

See Safety Section.

Time Frame 21 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety set was used for analysis, which consists of 54 patients, of whom 2 patients did not start treatment with any antidepressant
Arm/Group Title Fluoxetine and Fingolimod Venlafaxine and Fingolimod Citalopram and Fingolimod Fingolimod
Hide Arm/Group Description:
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
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
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
2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.
Overall Number of Participants Analyzed 17 15 20 54
Measure Type: Number
Unit of Measure: Participants
Any Adverse Event 11 12 12 15
Death 0 0 0 0
Serious Adverse Event 0 1 1 1
Time Frame [Not Specified]
Adverse Event Reporting Description The safety set (SS) consists of all enrolled patients for whom safety information was collected. Of note, the statement that a patient had no adverse events also constitutes a safety assessment. Fingolimod 2 week pretreatment included 2 patients who did not receive antidepressant.
 
Arm/Group Title Fingolimod Venlafaxine and Fingolimod Citalopram and Fingolimod Fluoxetine and Fingolimod
Hide Arm/Group Description 2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period. 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 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 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
All-Cause Mortality
Fingolimod Venlafaxine and Fingolimod Citalopram and Fingolimod Fluoxetine and Fingolimod
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fingolimod Venlafaxine and Fingolimod Citalopram and Fingolimod Fluoxetine and Fingolimod
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/54 (1.85%)   1/15 (6.67%)   1/20 (5.00%)   0/17 (0.00%) 
Nervous system disorders         
CEREBRAL HAEMORRHAGE  1  1/54 (1.85%)  0/15 (0.00%)  0/20 (0.00%)  0/17 (0.00%) 
MULTIPLE SCLEROSIS RELAPSE  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
Psychiatric disorders         
SUICIDAL IDEATION  1  0/54 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fingolimod Venlafaxine and Fingolimod Citalopram and Fingolimod Fluoxetine and Fingolimod
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/54 (27.78%)   12/15 (80.00%)   12/20 (60.00%)   11/17 (64.71%) 
Blood and lymphatic system disorders         
LYMPHOPENIA  1  6/54 (11.11%)  0/15 (0.00%)  0/20 (0.00%)  0/17 (0.00%) 
Cardiac disorders         
TACHYCARDIA  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
Eye disorders         
ASTHENOPIA  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
CONJUNCTIVAL HAEMORRHAGE  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
Gastrointestinal disorders         
ABDOMINAL PAIN  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
CONSTIPATION  1  0/54 (0.00%)  1/15 (6.67%)  1/20 (5.00%)  0/17 (0.00%) 
DIARRHOEA  1  0/54 (0.00%)  1/15 (6.67%)  1/20 (5.00%)  0/17 (0.00%) 
DRY MOUTH  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
GASTROINTESTINAL DISORDER  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
NAUSEA  1  0/54 (0.00%)  3/15 (20.00%)  4/20 (20.00%)  4/17 (23.53%) 
TOOTHACHE  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
General disorders         
FATIGUE  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  2/17 (11.76%) 
FEELING HOT  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
OEDEMA PERIPHERAL  1  0/54 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/17 (0.00%) 
PAIN  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
THIRST  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
Infections and infestations         
BRONCHITIS  1  0/54 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  1/17 (5.88%) 
GASTROINTESTINAL INFECTION  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
INFLUENZA  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  1/17 (5.88%) 
NASOPHARYNGITIS  1  2/54 (3.70%)  1/15 (6.67%)  1/20 (5.00%)  2/17 (11.76%) 
RHINITIS  1  0/54 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/17 (0.00%) 
TONSILLITIS  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  1/54 (1.85%)  0/15 (0.00%)  1/20 (5.00%)  0/17 (0.00%) 
Injury, poisoning and procedural complications         
CONTUSION  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
FALL  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
Investigations         
BLOOD BILIRUBIN INCREASED  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
ELECTROCARDIOGRAM ABNORMAL  1  1/54 (1.85%)  0/15 (0.00%)  1/20 (5.00%)  0/17 (0.00%) 
LABORATORY TEST ABNORMAL  1  1/54 (1.85%)  1/15 (6.67%)  1/20 (5.00%)  1/17 (5.88%) 
WEIGHT DECREASED  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  1/17 (5.88%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  0/54 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/17 (0.00%) 
ARTHRITIS  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
BACK PAIN  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
SKIN PAPILLOMA  1  0/54 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/17 (0.00%) 
Nervous system disorders         
DIZZINESS  1  0/54 (0.00%)  1/15 (6.67%)  1/20 (5.00%)  0/17 (0.00%) 
DYSGEUSIA  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
HEADACHE  1  1/54 (1.85%)  1/15 (6.67%)  1/20 (5.00%)  2/17 (11.76%) 
HYPOAESTHESIA  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
LOSS OF CONSCIOUSNESS  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
MULTIPLE SCLEROSIS RELAPSE  1  2/54 (3.70%)  2/15 (13.33%)  0/20 (0.00%)  2/17 (11.76%) 
OPTIC NEURITIS  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
PAROSMIA  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
SEDATION  1  0/54 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/17 (0.00%) 
SOMNOLENCE  1  1/54 (1.85%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
TREMOR  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
Psychiatric disorders         
AGITATION  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
INSOMNIA  1  1/54 (1.85%)  2/15 (13.33%)  0/20 (0.00%)  0/17 (0.00%) 
LIBIDO DISORDER  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
SLEEP DISORDER  1  0/54 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/17 (0.00%) 
Reproductive system and breast disorders         
EJACULATION DISORDER  1  0/54 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/17 (0.00%) 
METRORRHAGIA  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
DYSPNOEA  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
HICCUPS  1  0/54 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/17 (0.00%) 
RHINITIS ALLERGIC  1  0/54 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/17 (0.00%) 
YAWNING  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
Skin and subcutaneous tissue disorders         
ALOPECIA  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  2/17 (11.76%) 
DERMATITIS ALLERGIC  1  0/54 (0.00%)  0/15 (0.00%)  0/20 (0.00%)  1/17 (5.88%) 
ERYTHEMA  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
HYPERHIDROSIS  1  0/54 (0.00%)  2/15 (13.33%)  0/20 (0.00%)  1/17 (5.88%) 
SKIN LESION  1  0/54 (0.00%)  0/15 (0.00%)  1/20 (5.00%)  0/17 (0.00%) 
Vascular disorders         
FLUSHING  1  0/54 (0.00%)  1/15 (6.67%)  0/20 (0.00%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01436643     History of Changes
Other Study ID Numbers: CFTY720DDE06
2011-001692-39 ( EudraCT Number )
First Submitted: September 16, 2011
First Posted: September 20, 2011
Results First Submitted: September 1, 2014
Results First Posted: September 25, 2014
Last Update Posted: September 25, 2014