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

This study has been terminated.
(Due to slow enrollment the study was terminated early)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01436643
First received: September 16, 2011
Last updated: September 24, 2014
Last verified: September 2014
Results First Received: September 1, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Depression
Relapsing-remitting Multiple Sclerosis
Interventions: Drug: Venlafaxine
Drug: Fluoxetine
Drug: Citalopram
Drug: Fingolimod

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fluoxetine and Fingolimod 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
Venlafaxine and 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
Citalopram and 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
Pre-treatment With Fingolimod During 2weeks pre-treatment period patients received Fingolimod 0.5 mg per capsule (hard gelatin capsules) orally once daily.

Participant Flow for 2 periods

Period 1:   2-week Pre-treatment
    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 
Abnormal test result                0                0                0                1 
Adverse Event                0                0                0                5 
Protocol Violation                0                0                0                4 

Period 2:   Core Phase (16 Weeks)
    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 
Adverse Event                0                3                1                0 
Abnormal Test result                0                0                1                0 
Protocol Violation                1                1                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The safety set was used for analysis, which consists of 54 patients, of whom 2 patients did not start treatment with any antidepressant

Reporting Groups
  Description
Fluoxetine and Fingolimod 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
Venlafaxine and 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
Citalopram and 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
Total Total of all reporting groups

Baseline Measures
   Fluoxetine and Fingolimod   Venlafaxine and Fingolimod   Citalopram and Fingolimod   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   15   20   52 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.2  (9.22)   40.0  (9.28)   41.2  (10.22)   41.8  (9.87) 
Gender 
[Units: Participants]
       
Female   15   10   17   42 
Male   2   5   3   10 


  Outcome Measures

1.  Primary:   Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death   [ Time Frame: 21 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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 )
Study First Received: September 16, 2011
Results First Received: September 1, 2014
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices