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Efficacy and Tolerability of Riluzole in Treatment Resistant Depression

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ClinicalTrials.gov Identifier: NCT01204918
Recruitment Status : Completed
First Posted : September 17, 2010
Results First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: Riluzole
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Riluzole Addition to SSRI Antidepressant

Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks

Riluzole: Riluzole 100mg PO

Riluzole/Placebo Addition to SSRI Antidepressant

Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks

Riluzole: Riluzole 100mg PO

placebo: placebo

Placebo Addition to Standard SSRI Antidepressant

Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks

placebo: placebo


Participant Flow:   Overall Study
    Riluzole Addition to SSRI Antidepressant   Riluzole/Placebo Addition to SSRI Antidepressant   Placebo Addition to Standard SSRI Antidepressant
STARTED   25   39   40 
Stage 1 Begin   25   39   40 
Stage 1 End   22   35   36 
Stage 2 Begin   22   35   36 
Stage 2 End   21   29   35 
COMPLETED   21   29   35 
NOT COMPLETED   4   10   5 
Withdrawal by Subject                4                10                5 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Riluzole Addition to SSRI Antidepressant

Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 8 weeks

Riluzole: Riluzole 100mg PO

Riluzole/Placebo Addition to SSRI Antidepressant

Riluzole 100mg added to ongoing SSRI or SNRI antidepressant for 4 weeks and placebo will added to ongoing SSRI or SNRI antidepressant treatment for 4 weeks

Riluzole: Riluzole 100mg PO

placebo: placebo

Placebo Addition to Standard SSRI Antidepressant

Placebo will be added to ongoing SSRI or SNRI antidepressant treatment for 8 weeks

placebo: placebo

Total Total of all reporting groups

Baseline Measures
   Riluzole Addition to SSRI Antidepressant   Riluzole/Placebo Addition to SSRI Antidepressant   Placebo Addition to Standard SSRI Antidepressant   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   39   40   104 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.3  (12.7)   47.3  (12.1)   46.3  (12.7)   46.3  (12.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      9  36.0%      24  61.5%      21  52.5%      54  51.9% 
Male      16  64.0%      15  38.5%      19  47.5%      50  48.1% 
Antidepressant (Y/N) 
[Units: Participants]
Count of Participants
       
Yes   16   25   24   65 
No   9   14   16   39 


  Outcome Measures

1.  Primary:   Change in Montgomery and Asberg Depression Rating Scale (MADRS)   [ Time Frame: 4 weeks of therapy (baseline to week 4) ]

2.  Primary:   Change in Montgomery and Asberg Depression Rating Scale (MADRS)   [ Time Frame: 4 weeks of therapy (week 4 to week 8) ]

3.  Secondary:   Responders Having at Least a 50% Improvement in MADRS Compared to the Baseline   [ Time Frame: 8 weeks therapy ]

4.  Secondary:   Systematic Assessment for Treatment Emergent Events (SAFTEE-SI)   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gerard Sanacora, PhD, MD: Professor of Psychiatry; Director, Yale Depression Research Program
Organization: Yale University
phone: (203) 974-7535
e-mail: gerard.sanacora@yale.edu


Publications:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01204918     History of Changes
Obsolete Identifiers: NCT01298427
Other Study ID Numbers: HIC#0903004917
First Submitted: September 16, 2010
First Posted: September 17, 2010
Results First Submitted: October 10, 2017
Results First Posted: February 8, 2018
Last Update Posted: February 8, 2018