Trial Outcomes & Findings for Proof-of-Concept Trial of CERC-501 Augmentation of Antidepressant Therapy in Treatment-Resistant Depression (NCT NCT01913535)
NCT ID: NCT01913535
Last Updated: 2017-07-02
Results Overview
This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms. Total scores range from 0 (normal) to 22 (severe). To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
TERMINATED
PHASE2
8 participants
Baseline and 72 hours after initiating treatment
2017-07-02
Participant Flow
Only 8 participants were randomized because the study terminated early due to slow enrollment.
Participant milestones
| Measure |
Low Dose Drug-Drug Arm
Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).
|
High Dose Drug-Drug Arm
Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).
|
Placebo/Low-Dose Drug Arm
Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2)
CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).
For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.
|
Placebo/High-Dose Drug Arm
Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2)
CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).
|
Placebo/Placebo Arm
Patients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
Placebo: For patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days).
|
|---|---|---|---|---|---|
|
Phase 1 (Days 0-2)
STARTED
|
2
|
2
|
1
|
2
|
1
|
|
Phase 1 (Days 0-2)
COMPLETED
|
2
|
2
|
1
|
2
|
1
|
|
Phase 1 (Days 0-2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 (Days 3-5)
STARTED
|
2
|
2
|
1
|
2
|
1
|
|
Phase 2 (Days 3-5)
COMPLETED
|
2
|
2
|
1
|
2
|
1
|
|
Phase 2 (Days 3-5)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Proof-of-Concept Trial of CERC-501 Augmentation of Antidepressant Therapy in Treatment-Resistant Depression
Baseline characteristics by cohort
| Measure |
Low Dose Drug-Drug Arm
n=2 Participants
Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).
|
High Dose Drug-Drug Arm
n=2 Participants
Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).
|
Placebo/Low-Dose Drug Arm
n=1 Participants
Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2)
CERC-501: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).
|
Placebo/High-Dose Drug Arm
n=2 Participants
Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2)
CERC-501: High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).
|
Placebo/Placebo Arm
n=1 Participants
Patients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.2 years
n=5 Participants
|
58.3 years
n=7 Participants
|
34.5 years
n=5 Participants
|
36.3 years
n=4 Participants
|
38.8 years
n=21 Participants
|
48.8 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and 72 hours after initiating treatmentPopulation: In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.
This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms. Total scores range from 0 (normal) to 22 (severe). To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Outcome measures
| Measure |
CERC-501
n=7 Participants
either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
Placebo
n=5 Participants
Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
|---|---|---|
|
Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)
|
-3 units on a scale
Interval -13.5 to 0.0
|
0 units on a scale
Interval -6.0 to 1.5
|
SECONDARY outcome
Timeframe: Baseline and 20 days after initiating treatmentPopulation: The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms. 2 participants were in low dose drug-drug arm, 2 participants were in high dose drug-drug arm, and 1 participant was in the placebo-placebo arm. One drug-drug pt missing day 20 data.
This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms. Total scores range from 0 (normal) to 22 (severe). To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Outcome measures
| Measure |
CERC-501
n=3 Participants
either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
Placebo
n=1 Participants
Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
|---|---|---|
|
Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6), Day 20
|
-3.5 units on a scale
Interval -5.5 to -0.5
|
-3.5 units on a scale
Interval -3.5 to -3.5
|
SECONDARY outcome
Timeframe: 72 hours after treatment initiationPopulation: In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.
Compare response rates at 72 hours for of patients treated with either dose (10 mg/day or 20 mg/day) of CERC-501 to those assigned to placebo therapy, using the Sequential Parallel Comparison Design (SPCD), with response defined as a 50% or greater reduction from baseline to Day 3 on the HAM-D-6 total score). To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline. The HAM-D-6 instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms.
Outcome measures
| Measure |
CERC-501
n=7 Participants
either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
Placebo
n=5 Participants
Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
|---|---|---|
|
Number of Participants With Response on Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and 72 hours and 20 days after initiating treatmentPopulation: In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.
The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity (in past 3 days), was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression. To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Outcome measures
| Measure |
CERC-501
n=7 Participants
either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
Placebo
n=5 Participants
Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
|---|---|---|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
72-hour change
|
-6.5 units on a scale
Interval -33.0 to 0.0
|
-4.5 units on a scale
Interval -17.0 to 3.0
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
20-day change
|
-8 units on a scale
Interval -15.5 to -4.5
|
-9 units on a scale
Interval -9.0 to -9.0
|
SECONDARY outcome
Timeframe: Baseline and 72 hours and 20 days after initiating treatmentPopulation: In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.
The CGI-S scale was administered by clinicians to measure depressive severity (CGI-S). Each item is rated on a seven-point scale (1=normal to 7=among the most severe), so a higher total score indicates greater depressive severity. Severity is assessed based on the last 24 hours. To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Outcome measures
| Measure |
CERC-501
n=7 Participants
either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
Placebo
n=5 Participants
Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
|---|---|---|
|
Change in Clinical Global Impression -Severity (CGI-S)
20-day change
|
-1 units on a scale
Interval -1.5 to 0.0
|
-1 units on a scale
Interval -1.0 to -1.0
|
|
Change in Clinical Global Impression -Severity (CGI-S)
72-hour change
|
-0.5 units on a scale
Interval -4.0 to 0.0
|
0 units on a scale
Interval -3.0 to 0.5
|
SECONDARY outcome
Timeframe: 72 hours and 20 days after initiating treatmentPopulation: In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria.The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.
The CGI-I scale was administered by clinicians to measure improvement in depressive severity (CGI-I). Each item is rated on a seven-point scale (1=very much improved to 7=very much worse), so a higher total score indicates less improvement in depressive severity. Improvement is assessed based on the last 24 hours.
Outcome measures
| Measure |
CERC-501
n=7 Participants
either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
Placebo
n=5 Participants
Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
|---|---|---|
|
Clinical Global Impression-Improvement (CGI-I)
72 hours
|
3 units on a scale
Interval 1.0 to 4.0
|
4 units on a scale
Interval 2.0 to 4.0
|
|
Clinical Global Impression-Improvement (CGI-I)
20 days
|
3 units on a scale
Interval 3.0 to 4.0
|
4 units on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline and 72 hours and 20 days after initiating treatmentPopulation: In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.
This validated self-rating instrument has 44 items on a scale of 1-6, measuring multiple depressive symptom domains. Each item is rated based on a subject's perception of what is normal for the individual (score = 2), what is better than normal (score = 1), and what is worse than normal (scores = 3-6). This scale is rated based on the past 24 hours. A total score is calculated by summing the 44 item scores, for a range of 0-264. To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Outcome measures
| Measure |
CERC-501
n=7 Participants
either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
Placebo
n=5 Participants
Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
|---|---|---|
|
Change in Symptoms of Depression Questionnaire (SDQ)
72-hour change
|
-26 units on a scale
Interval -69.5 to 0.0
|
-7.5 units on a scale
Interval -48.0 to 5.0
|
|
Change in Symptoms of Depression Questionnaire (SDQ)
20-day change
|
-15.5 units on a scale
Interval -38.5 to -8.5
|
-3.5 units on a scale
Interval -3.5 to -3.5
|
SECONDARY outcome
Timeframe: Baseline and 72 hours and 20 days after treatment initiationPopulation: In the sequential parallel comparison design (SPCD) analyses through 72 hrs, placebo non-responders are included from phase 2 and are pooled with phase 1. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. 2 pts missing 72-hr PSS values. The 20-day analyses only use drug-drug and placebo-placebo arms.
This is a 10-item, validated, self-rated measure of perceived stress, that is of the degree to which the subjects perceives things to be stressful and overwhelming. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. This scale is rated based on the past 24 hours. To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Outcome measures
| Measure |
CERC-501
n=6 Participants
either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
Placebo
n=4 Participants
Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
|---|---|---|
|
Change in Perceived Stress Scale (PSS)
72-hour change
|
-3.5 units on a scale
Interval -13.0 to -1.0
|
-1.25 units on a scale
Interval -2.0 to 2.5
|
|
Change in Perceived Stress Scale (PSS)
20-day change
|
-7.25 units on a scale
Interval -12.0 to -2.5
|
0.5 units on a scale
Interval 0.5 to 0.5
|
SECONDARY outcome
Timeframe: Baseline and 72 hours and 20 days after initiating treatmentPopulation: In the sequential parallel comparison design (SPCD) analyses through 72 hrs, placebo non-responder data is included from phase 2 and is pooled with phase 1. All phase 1 placebo participants were non-responders based on HAM-D-6 and MADRS criteria.The 20-day analyses only use drug-drug (either dose) and placebo-placebo arms. 1 pt missing PAS data.
This is a validated, self-rated measure of positive affect uses 5-point scales (1 = very slightly/not at all to 5 = extremely). Higher scores represent higher levels of positive affect. The scale is rated based on the past 24 hours. The total score is the sum of 10 items, for a range of 10-50. To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Outcome measures
| Measure |
CERC-501
n=6 Participants
either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
Placebo
n=5 Participants
Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
|---|---|---|
|
Change in Positive Affect Scale (PAS)
72-hour change
|
8 units on a scale
Interval -5.5 to 19.0
|
17.5 units on a scale
Interval -25.5 to 31.0
|
|
Change in Positive Affect Scale (PAS)
20-day change
|
11 units on a scale
Interval 5.0 to 16.5
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and 72 hours and 20 days after initiating treatmentPopulation: In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria.The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.
These are two well-validated 7-item self-rating scales that measure social health. A higher score represents higher satisfaction on each scale. The scales are rated based on the past 24 hours. Each item is rated 1-5 (1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much). Each 7-item subscale score is the sum of each of the 7 items and ranges from 7-35. To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Outcome measures
| Measure |
CERC-501
n=7 Participants
either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
Placebo
n=5 Participants
Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction With Participation in Social Roles and Discretionary Activities
Social Roles 72-hour change
|
2.5 units on a scale
Interval -4.0 to 11.5
|
1.5 units on a scale
Interval -4.0 to 11.0
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction With Participation in Social Roles and Discretionary Activities
Social Roles 20-day change
|
-1.5 units on a scale
Interval -3.0 to 7.0
|
3 units on a scale
Interval 3.0 to 3.0
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction With Participation in Social Roles and Discretionary Activities
Discretionary Activities 72-hour change
|
3 units on a scale
Interval 0.0 to 16.0
|
1.5 units on a scale
Interval -2.5 to 6.0
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction With Participation in Social Roles and Discretionary Activities
Discretionary Activities 20-day change
|
4 units on a scale
Interval -1.0 to 7.5
|
5 units on a scale
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline and 72 hours after initiating treatmentPopulation: In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria. 1 CERC-501 pt and 3 placebo pts are missing data on 72-hr change values.
The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior. It is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the level and type of suicidality present. The C-SSRS will be performed to assess suicidal ideation and behavior. It contains a 5-item rating scale for suicidal ideation and a 7-item rating scale for suicidal behavior. Higher total scores indicate higher severity. Each item is coded 1=yes, 0=no, so a total score of 0 on each scale means that a no response was entered for each of the 5 suicidal ideation and for each of the 7 suicidal behavior questions, i.e., 0=lowest severity score. Total suicidal ideation score ranges from 0 (least severe) to 5 (most severe). Total suicidal behavior score ranges from 0 (least severe) to 7 (most severe).
Outcome measures
| Measure |
CERC-501
n=6 Participants
either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
Placebo
n=2 Participants
Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
|---|---|---|
|
Change in the Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation
|
0 units on a scale
Interval -2.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Change in the Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 72 hours after treatment initiationPopulation: In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.
Number of Participants with clinically significant abnormal electrocardiogram (ECG)
Outcome measures
| Measure |
CERC-501
n=7 Participants
either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
Placebo
n=5 Participants
Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormal ECG
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 72 hours after treatment initiationPopulation: In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.
Total number of participants with clinically significant abnormal labs
Outcome measures
| Measure |
CERC-501
n=7 Participants
either dose (10 mg/day or 20 mg/day) of CERC-501; pooled patients from phase 1 and those on drug in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
Placebo
n=5 Participants
Placebo therapy; pooled those on placebo in phase 1 with those on placebo in phase 2 who were placebo non-responders from phase 1.
Response is defined as a 50% or greater reduction from baseline to Day 3 on the Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) total score and a Montgomery-Asberg Depression Rating Scale (MADRS) score of 16 or more at day 3.
|
|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Labs
Any lab
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Labs
Total RBC
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Abnormal Labs
Hematocrit
|
1 Participants
|
1 Participants
|
Adverse Events
Low Dose Drug
High Dose Drug
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose Drug
n=3 participants at risk
Patients receive CERC-501 10.0 mg/day
|
High Dose Drug
n=4 participants at risk
Patients receive CERC-501 20.0 mg/day
|
Placebo
n=4 participants at risk
Patients receive placebo
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Acne
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Nervous system disorders
Central Nervous Systems Lesions
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Gastrointestinal disorders
Gastrointestinal disturbance
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/4
|
|
Renal and urinary disorders
Microscopic hematuria (grade 1)
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Remembered dreams (unusual for subject)
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
|
Renal and urinary disorders
Renal calculi (Grade 2)
|
0.00%
0/3
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
|
Psychiatric disorders
Worsening depression
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
itching on thighs
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place