Trial Outcomes & Findings for Riluzole Augmentation Pilot in Depression (RAPID) Trial (NCT NCT01703039)

Last Updated: 2019-08-28

Results Overview

The Hamilton Depression Rating Scale (HDRS) is a clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher HDRS scores indicate a worse outcome. The scale has a minimum value of 0 and a maximum value of 52.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

0 weeks-8 weeks

Results posted on

2019-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Sertraline + Riluzole sertraline 100 mg po daily and riluzole 50 mg po bid Riluzole Sertraline	Sertraline + Placebo sertraline 100 mg po daily and placebo Sertraline placebo
Overall Study STARTED	9	12
Overall Study COMPLETED	6	7
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Riluzole Augmentation Pilot in Depression (RAPID) Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sertraline + Riluzole n=6 Participants sertraline 100 mg po daily and riluzole 50 mg po bid Riluzole Sertraline	Sertraline + Placebo n=7 Participants sertraline 100 mg po daily and placebo Sertraline placebo	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	53.83 years STANDARD_DEVIATION 14.88 • n=5 Participants	52.86 years STANDARD_DEVIATION 7.71 • n=7 Participants	53.31 years STANDARD_DEVIATION 11.06 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Hamilton Depression Rating Scale (HDRS)	26 units on a scale STANDARD_DEVIATION 2.53 • n=5 Participants	25.14 units on a scale STANDARD_DEVIATION 2.97 • n=7 Participants	25.54 units on a scale STANDARD_DEVIATION 2.70 • n=5 Participants
Hamilton Anxiety Rating Scale (HARS)	29.83 units on a scale STANDARD_DEVIATION 7.33 • n=5 Participants	27.14 units on a scale STANDARD_DEVIATION 10.12 • n=7 Participants	28.38 units on a scale STANDARD_DEVIATION 8.69 • n=5 Participants
Clinical Global Impression Scale (CGI)	5 units on a scale STANDARD_DEVIATION 0.63 • n=5 Participants	5.14 units on a scale STANDARD_DEVIATION 0.90 • n=7 Participants	5.08 units on a scale STANDARD_DEVIATION 0.76 • n=5 Participants

PRIMARY outcome

Timeframe: 0 weeks-8 weeks

Outcome measures

Outcome measures
Measure	Sertraline + Riluzole n=6 Participants sert 100mg po daily and riluzole...	Sertraline + Placebo n=7 Participants sert 100mg po daily and placebo...
Mean Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks	-5.67 score on a scale Standard Deviation 7.09	-13.43 score on a scale Standard Deviation 6.53

PRIMARY outcome

Timeframe: 0 weeks-8 weeks

Outcome measures

Outcome measures
Measure	Sertraline + Riluzole n=6 Participants sert 100mg po daily and riluzole...	Sertraline + Placebo n=7 Participants sert 100mg po daily and placebo...
Number of Patients Experiencing an Antidepressant Response (>50% Reduction in HDRS) at Endpoint of 8 Weeks	1 Participants	3 Participants

PRIMARY outcome

Timeframe: 0 weeks-8 weeks

Outcome measures

Outcome measures
Measure	Sertraline + Riluzole n=6 Participants sert 100mg po daily and riluzole...	Sertraline + Placebo n=7 Participants sert 100mg po daily and placebo...
Number of Patients Experiencing Remission From Depression (HDRS<7) at Endpoint of 8 Weeks	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 0 weeks-8 weeks

The HARS scale is a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It has 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicate less anxiety.

Outcome measures

Outcome measures
Measure	Sertraline + Riluzole n=6 Participants sert 100mg po daily and riluzole...	Sertraline + Placebo n=7 Participants sert 100mg po daily and placebo...
Mean Change in Hamilton Anxiety Rating Scale (HARS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks	-9.50 score on a scale Standard Deviation 10.88	-15.57 score on a scale Standard Deviation 7.72

SECONDARY outcome

Timeframe: 0 weeks-8 weeks

The Clinical Global Impression Scale (CGI) is a brief clinician-rated instrument. The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Treatment response ratings should take account of both therapeutic efficacy and treatment-related adverse events and range from 0 (marked improvement and no side-effects) and 4 (unchanged or worse and side-effects outweigh the therapeutic effects). Each component of the CGI is rated separately; the instrument does not yield a global score.

Outcome measures

Outcome measures
Measure	Sertraline + Riluzole n=6 Participants sert 100mg po daily and riluzole...	Sertraline + Placebo n=7 Participants sert 100mg po daily and placebo...
Mean Change in Clinical Global Impression (CGI) Scale From Baseline (0 Weeks) to Endpoint at 8 Weeks	-0.67 score on a scale Standard Deviation 0.82	-2.71 score on a scale Standard Deviation 1.98

Adverse Events

Sertraline + Riluzole

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sertraline + Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sertraline + Riluzole n=9 participants at risk sertraline 100 mg po daily and riluzole 50 mg po bid Riluzole Sertraline	Sertraline + Placebo n=12 participants at risk sertraline 100 mg po daily and placebo Sertraline placebo
Gastrointestinal disorders Nausea	11.1% 1/9 • 8 weeks	0.00% 0/12 • 8 weeks
Gastrointestinal disorders Elevated Liver Function Tests (LFTs)	11.1% 1/9 • 8 weeks	16.7% 2/12 • 8 weeks

Additional Information

Dr. Jessica Harder

Brigham and Women's Hospital

Phone: 617-525-7919

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place