Trial Outcomes & Findings for Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine (NCT NCT02304432)
NCT ID: NCT02304432
Last Updated: 2017-09-19
Results Overview
Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
2 participants
Primary outcome timeframe
Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2
Results posted on
2017-09-19
Participant Flow
Participant milestones
| Measure |
Open Label DCS
Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule for 8 weeks.
D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.
|
Placebo First, Then DCS
One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
Randomized to DCS or placebo. Participants underwent double-blind placebo-controlled exposures to DCS for 6 weeks or placebo for 6 weeks. One participant received exposure to DCS for 6 weeks and then received placebo dosing for 6 weeks. The other participant received exposure to placebo dosing for 6 weeks and then DCS for 6 weeks.
D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.
DCS or placebo: Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks.
|
DCS First, Then Placebo
One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
|
Second Open Label DCS
Both participants received second open label exposures to D-cycloserine (seromycin), 50 mg/d capsule for 24 weeks.
D-cycloserine: Both participants received second open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.
|
|---|---|---|---|---|
|
Open Label DCS
STARTED
|
2
|
0
|
0
|
0
|
|
Open Label DCS
COMPLETED
|
2
|
0
|
0
|
0
|
|
Open Label DCS
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Double-Blind DCS Placebo Crossover
STARTED
|
0
|
1
|
1
|
0
|
|
Double-Blind DCS Placebo Crossover
COMPLETED
|
0
|
1
|
1
|
0
|
|
Double-Blind DCS Placebo Crossover
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Open Label DCS
STARTED
|
0
|
0
|
0
|
2
|
|
Second Open Label DCS
COMPLETED
|
0
|
0
|
0
|
2
|
|
Second Open Label DCS
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine
Baseline characteristics by cohort
| Measure |
All Study Participants
n=2 Participants
Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule for 8 weeks.
D-cycloserine: Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.
Add crossover phase and second OL phase
|
|---|---|
|
Age, Continuous
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.
Outcome measures
| Measure |
First Open Label DCS
n=2 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
n=2 Participants
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Positive and Negative Symptom Scores
Baseline positive
|
14.5 units on a scale
Interval 12.0 to 17.0
|
11 units on a scale
Interval 9.0 to 13.0
|
|
Positive and Negative Symptom Scores
Baseline negative
|
14.5 units on a scale
Interval 11.0 to 18.0
|
14 units on a scale
Interval 11.0 to 17.0
|
|
Positive and Negative Symptom Scores
2 weeks positive
|
10 units on a scale
Interval 9.0 to 11.0
|
11 units on a scale
Interval 9.0 to 13.0
|
|
Positive and Negative Symptom Scores
2 weeks negative
|
12 units on a scale
Interval 9.0 to 15.0
|
14 units on a scale
Interval 11.0 to 17.0
|
|
Positive and Negative Symptom Scores
4 weeks positive
|
10.5 units on a scale
Interval 10.0 to 11.0
|
10.5 units on a scale
Interval 9.0 to 12.0
|
|
Positive and Negative Symptom Scores
4 weeks negative
|
12 units on a scale
Interval 9.0 to 15.0
|
13.5 units on a scale
Interval 11.0 to 16.0
|
|
Positive and Negative Symptom Scores
6 weeks positive
|
9 units on a scale
Interval 8.0 to 10.0
|
9 units on a scale
Interval 8.0 to 10.0
|
|
Positive and Negative Symptom Scores
6 weeks negative
|
12 units on a scale
Interval 9.0 to 15.0
|
13 units on a scale
Interval 11.0 to 15.0
|
|
Positive and Negative Symptom Scores
8 weeks positive
|
9 units on a scale
Interval 8.0 to 10.0
|
9.5 units on a scale
Interval 8.0 to 11.0
|
|
Positive and Negative Symptom Scores
8 weeks negative
|
12 units on a scale
Interval 9.0 to 15.0
|
12 units on a scale
Interval 9.0 to 15.0
|
|
Positive and Negative Symptom Scores
10 weeks positive
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
10.5 units on a scale
Interval 10.0 to 11.0
|
|
Positive and Negative Symptom Scores
10 weeks negative
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
13 units on a scale
Interval 11.0 to 15.0
|
|
Positive and Negative Symptom Scores
12 weeks positive
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
11 units on a scale
Interval 9.0 to 13.0
|
|
Positive and Negative Symptom Scores
12 weeks negative
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
12 units on a scale
Interval 9.0 to 15.0
|
|
Positive and Negative Symptom Scores
14 weeks positive
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
10 units on a scale
Interval 8.0 to 12.0
|
|
Positive and Negative Symptom Scores
14 weeks negative
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
12 units on a scale
Interval 9.0 to 15.0
|
|
Positive and Negative Symptom Scores
16 weeks positive
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
10.5 units on a scale
Interval 10.0 to 11.0
|
|
Positive and Negative Symptom Scores
16 weeks negative
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
12 units on a scale
Interval 9.0 to 15.0
|
|
Positive and Negative Symptom Scores
18 weeks positive
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
10.5 units on a scale
Interval 9.0 to 12.0
|
|
Positive and Negative Symptom Scores
18 weeks negative
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
12 units on a scale
Interval 9.0 to 15.0
|
|
Positive and Negative Symptom Scores
20 weeks positive
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
10.5 units on a scale
Interval 9.0 to 12.0
|
|
Positive and Negative Symptom Scores
20 weeks negative
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
12 units on a scale
Interval 9.0 to 15.0
|
|
Positive and Negative Symptom Scores
22 weeks positive
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
9.5 units on a scale
Interval 8.0 to 11.0
|
|
Positive and Negative Symptom Scores
22 weeks negative
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
12 units on a scale
Interval 9.0 to 15.0
|
|
Positive and Negative Symptom Scores
24 weeks positive
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
10 units on a scale
Interval 8.0 to 12.0
|
|
Positive and Negative Symptom Scores
24 weeks negative
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
12 units on a scale
Interval 9.0 to 15.0
|
PRIMARY outcome
Timeframe: Baseline, 2, 4, & 6 weeks (crossover periods)Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.
Outcome measures
| Measure |
First Open Label DCS
n=1 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
n=1 Participants
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Positive and Negative Symptom Scores
Baseline positive for first intervention
|
11 units on a scale
|
10 units on a scale
|
|
Positive and Negative Symptom Scores
Baseline negative symptoms for first intervention
|
9 units on a scale
|
15 units on a scale
|
|
Positive and Negative Symptom Scores
2 weeks positive for first intervention
|
12 units on a scale
|
10 units on a scale
|
|
Positive and Negative Symptom Scores
2 weeks negative for first intervention
|
15 units on a scale
|
15 units on a scale
|
|
Positive and Negative Symptom Scores
4 weeks positive for first intervention
|
11 units on a scale
|
10 units on a scale
|
|
Positive and Negative Symptom Scores
4 weeks negative for first intervention
|
13 units on a scale
|
15 units on a scale
|
|
Positive and Negative Symptom Scores
6 weeks positive for first intervention
|
13 units on a scale
|
10 units on a scale
|
|
Positive and Negative Symptom Scores
6 weeks negative for first intervention
|
13 units on a scale
|
15 units on a scale
|
|
Positive and Negative Symptom Scores
Baseline positive for second intervention
|
13 units on a scale
|
15 units on a scale
|
|
Positive and Negative Symptom Scores
Baseline negative for second intervention
|
13 units on a scale
|
18 units on a scale
|
|
Positive and Negative Symptom Scores
2 weeks positive for second intervention
|
10 units on a scale
|
15 units on a scale
|
|
Positive and Negative Symptom Scores
2 weeks negative for second intervention
|
11 units on a scale
|
18 units on a scale
|
|
Positive and Negative Symptom Scores
4 weeks positive for second intervention
|
9 units on a scale
|
15 units on a scale
|
|
Positive and Negative Symptom Scores
4 weeks negative for second intervention
|
11 units on a scale
|
18 units on a scale
|
|
Positive and Negative Symptom Scores
6 weeks positive for second intervention
|
9 units on a scale
|
14 units on a scale
|
|
Positive and Negative Symptom Scores
6 weeks negative for second intervention
|
11 units on a scale
|
18 units on a scale
|
PRIMARY outcome
Timeframe: Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.
Outcome measures
| Measure |
First Open Label DCS
n=2 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
n=2 Participants
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS) Scores
Baseline BPRS
|
37 units on a scale
Interval 34.0 to 40.0
|
31.5 units on a scale
Interval 28.0 to 35.0
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
2 weeks BPRS
|
25 units on a scale
Interval 22.0 to 28.0
|
30.5 units on a scale
Interval 27.0 to 34.0
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
4 weeks BPRS
|
26 units on a scale
Interval 24.0 to 28.0
|
28 units on a scale
Interval 27.0 to 29.0
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
6 weeks BPRS
|
24 units on a scale
Interval 22.0 to 26.0
|
25.5 units on a scale
Interval 25.0 to 26.0
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
8 weeks BPRS
|
24.5 units on a scale
Interval 23.0 to 26.0
|
26 units on a scale
Interval 24.0 to 28.0
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
10 weeks BPRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
26.5 units on a scale
Interval 26.0 to 27.0
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
12 weeks BPRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
26 units on a scale
Interval 24.0 to 28.0
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
14 weeks BPRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
25.5 units on a scale
Interval 24.0 to 27.0
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
16 weeks BPRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
28.5 units on a scale
Interval 27.0 to 30.0
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
18 weeks BPRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
27 units on a scale
Interval 25.0 to 29.0
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
20 weeks BPRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
25 units on a scale
Interval 23.0 to 27.0
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
22 weeks BPRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
24.5 units on a scale
Interval 22.0 to 27.0
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
24 weeks BPRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
26.5 units on a scale
Interval 25.0 to 28.0
|
PRIMARY outcome
Timeframe: Baseline, 2, 4, & 6 weeks (crossover periods)Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.
Outcome measures
| Measure |
First Open Label DCS
n=1 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
n=1 Participants
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS) Scores
Baseline BPRS for first intervention
|
29 units on a scale
|
26 units on a scale
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
2 weeks BPRS for first intervention
|
35 units on a scale
|
25 units on a scale
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
4 weeks BPRS for first intervention
|
33 units on a scale
|
25 units on a scale
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
6 weeks BPRS for first intervention
|
35 units on a scale
|
26 units on a scale
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
Baseline BPRS for second intervention
|
36 units on a scale
|
39 units on a scale
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
2 weeks BPRS for second intervention
|
30 units on a scale
|
45 units on a scale
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
4 weeks BPRS for second intervention
|
27 units on a scale
|
45 units on a scale
|
|
Brief Psychiatric Rating Scale (BPRS) Scores
6 weeks BPRS for second intervention
|
28 units on a scale
|
38 units on a scale
|
PRIMARY outcome
Timeframe: Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.
Outcome measures
| Measure |
First Open Label DCS
n=2 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
n=2 Participants
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Clinical Global Impression (CGI) Severity Scores
Baseline CGI
|
4 units on a scale
Interval 4.0 to 4.0
|
2.5 units on a scale
Interval 2.0 to 3.0
|
|
Clinical Global Impression (CGI) Severity Scores
2 weeks CGI
|
2 units on a scale
Interval 2.0 to 2.0
|
2.5 units on a scale
Interval 2.0 to 3.0
|
|
Clinical Global Impression (CGI) Severity Scores
4 weeks CGI
|
2 units on a scale
Interval 2.0 to 2.0
|
2.5 units on a scale
Interval 2.0 to 3.0
|
|
Clinical Global Impression (CGI) Severity Scores
6 weeks CGI
|
2 units on a scale
Interval 2.0 to 2.0
|
2.5 units on a scale
Interval 2.0 to 3.0
|
|
Clinical Global Impression (CGI) Severity Scores
8 weeks CGI
|
2 units on a scale
Interval 2.0 to 2.0
|
2.5 units on a scale
Interval 2.0 to 3.0
|
|
Clinical Global Impression (CGI) Severity Scores
10 weeks CGI
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
3 units on a scale
Interval 3.0 to 3.0
|
|
Clinical Global Impression (CGI) Severity Scores
12 weeks CGI
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
2.5 units on a scale
Interval 2.0 to 3.0
|
|
Clinical Global Impression (CGI) Severity Scores
14 weeks CGI
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
2 units on a scale
Interval 2.0 to 2.0
|
|
Clinical Global Impression (CGI) Severity Scores
16 weeks CGI
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
2.5 units on a scale
Interval 2.0 to 3.0
|
|
Clinical Global Impression (CGI) Severity Scores
18 weeks CGI
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
2.5 units on a scale
Interval 2.0 to 3.0
|
|
Clinical Global Impression (CGI) Severity Scores
20 weeks CGI
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
2.5 units on a scale
Interval 2.0 to 3.0
|
|
Clinical Global Impression (CGI) Severity Scores
22 weeks CGI
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
2.5 units on a scale
Interval 2.0 to 3.0
|
|
Clinical Global Impression (CGI) Severity Scores
24 weeks CGI
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
2.5 units on a scale
Interval 2.0 to 3.0
|
PRIMARY outcome
Timeframe: Baseline, 2, 4, & 6 weeks (crossover periods)CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.
Outcome measures
| Measure |
First Open Label DCS
n=1 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
n=1 Participants
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Clinical Global Impression (CGI) Severity Scores
Baseline CGI for first intervention
|
1 units on a scale
|
2 units on a scale
|
|
Clinical Global Impression (CGI) Severity Scores
2 weeks CGI for first intervention
|
3 units on a scale
|
2 units on a scale
|
|
Clinical Global Impression (CGI) Severity Scores
4 weeks CGI for first intervention
|
3 units on a scale
|
2 units on a scale
|
|
Clinical Global Impression (CGI) Severity Scores
6 weeks CGI for first intervention
|
3 units on a scale
|
2 units on a scale
|
|
Clinical Global Impression (CGI) Severity Scores
Baseline CGI for second intervention
|
3 units on a scale
|
3 units on a scale
|
|
Clinical Global Impression (CGI) Severity Scores
2 weeks CGI for second intervention
|
2 units on a scale
|
3 units on a scale
|
|
Clinical Global Impression (CGI) Severity Scores
4 weeks CGI for second intervention
|
2 units on a scale
|
3 units on a scale
|
|
Clinical Global Impression (CGI) Severity Scores
6 weeks CGI for second intervention
|
2 units on a scale
|
3 units on a scale
|
PRIMARY outcome
Timeframe: Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.
Outcome measures
| Measure |
First Open Label DCS
n=2 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
n=2 Participants
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Mania Symptom Scores
Baseline YMRS
|
2 units on a scale
Interval 2.0 to 2.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Mania Symptom Scores
2 weeks YMRS
|
1 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Mania Symptom Scores
4 weeks YMRS
|
1 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Mania Symptom Scores
6 weeks YMRS
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Mania Symptom Scores
8 weeks YMRS
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Mania Symptom Scores
10 weeks YMRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Mania Symptom Scores
12 weeks YMRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Mania Symptom Scores
14 weeks YMRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Mania Symptom Scores
16 weeks YMRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Mania Symptom Scores
18 weeks YMRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Mania Symptom Scores
20 weeks YMRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Mania Symptom Scores
22 weeks YMRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Mania Symptom Scores
24 weeks YMRS
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
1 units on a scale
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms.
Outcome measures
| Measure |
First Open Label DCS
n=2 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
n=2 Participants
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Depression Symptom Scores
Baseline HAM
|
5 units on a scale
Interval 4.0 to 6.0
|
0.5 units on a scale
Interval 0.0 to 1.0
|
|
Depression Symptom Scores
2 weeks HAM
|
1.5 units on a scale
Interval 0.0 to 3.0
|
1 units on a scale
Interval 1.0 to 1.0
|
|
Depression Symptom Scores
4 weeks HAM
|
1 units on a scale
Interval 0.0 to 2.0
|
1 units on a scale
Interval 0.0 to 2.0
|
|
Depression Symptom Scores
6 weeks HAM
|
0.5 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Depression Symptom Scores
8 weeks HAM
|
1.5 units on a scale
Interval 0.0 to 3.0
|
2.5 units on a scale
Interval 0.0 to 5.0
|
|
Depression Symptom Scores
10 weeks HAM
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Depression Symptom Scores
12 weeks HAM
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Depression Symptom Scores
14 weeks HAM
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Depression Symptom Scores
16 weeks HAM
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
3.5 units on a scale
Interval 0.0 to 7.0
|
|
Depression Symptom Scores
18 weeks HAM
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Depression Symptom Scores
20 weeks HAM
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Depression Symptom Scores
22 weeks HAM
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
|
Depression Symptom Scores
24 weeks HAM
|
NA units on a scale
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
|
0 units on a scale
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline, 2, 4, & 6 weeks (crossover periods)Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.
Outcome measures
| Measure |
First Open Label DCS
n=1 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
n=1 Participants
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Mania Symptom Scores
Baseline YMRS for first intervention
|
1 units on a scale
|
0 units on a scale
|
|
Mania Symptom Scores
2 weeks YMRS for first intervention
|
0 units on a scale
|
0 units on a scale
|
|
Mania Symptom Scores
4 weeks YMRS for first intervention
|
0 units on a scale
|
0 units on a scale
|
|
Mania Symptom Scores
6 weeks YMRS for first intervention
|
0 units on a scale
|
0 units on a scale
|
|
Mania Symptom Scores
Baseline YMRS for second intervention
|
4 units on a scale
|
0 units on a scale
|
|
Mania Symptom Scores
2 weeks YMRS for second intervention
|
1 units on a scale
|
0 units on a scale
|
|
Mania Symptom Scores
4 weeks YMRS for second intervention
|
1 units on a scale
|
0 units on a scale
|
|
Mania Symptom Scores
6 weeks YMRS for second intervention
|
1 units on a scale
|
0 units on a scale
|
PRIMARY outcome
Timeframe: Baseline, 2, 4, & 6 weeks (crossover periods)Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms.
Outcome measures
| Measure |
First Open Label DCS
n=1 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
n=1 Participants
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Depression Symptom Scores
Baseline HAM for first intervention
|
4 units on a scale
|
0 units on a scale
|
|
Depression Symptom Scores
2 weeks HAM for first intervention
|
5 units on a scale
|
1 units on a scale
|
|
Depression Symptom Scores
4 weeks HAM for first intervention
|
2 units on a scale
|
0 units on a scale
|
|
Depression Symptom Scores
6 weeks HAM for first intervention
|
10 units on a scale
|
0 units on a scale
|
|
Depression Symptom Scores
Baseline HAM for second intervention
|
0 units on a scale
|
2 units on a scale
|
|
Depression Symptom Scores
2 weeks HAM for second intervention
|
0 units on a scale
|
12 units on a scale
|
|
Depression Symptom Scores
4 weeks HAM for second intervention
|
0 units on a scale
|
9 units on a scale
|
|
Depression Symptom Scores
6 weeks HAM for second intervention
|
0 units on a scale
|
2 units on a scale
|
SECONDARY outcome
Timeframe: Baseline and Week 8 of open-label DCS treatmentPopulation: The on DCS data were collected during week 8 of the first open-label portion of the study in one subject and in week 8 of the second open-label portion of the study in the other subject for logistical reasons.
Scores on each of 8 domains of cognitive function (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning/problem solving, social cognition, overall composite). Scores are T scores ranging from 0-100, with 50 representing the mean for a population based on a normal distribution, standard deviation of 10. Higher scores signify better functioning.
Outcome measures
| Measure |
First Open Label DCS
n=2 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Neurocognitive Function
Baseline Processing Speed
|
48.5 T scores
Interval 43.0 to 54.0
|
—
|
|
Neurocognitive Function
Baseline Attention/Vigilance
|
44.5 T scores
Interval 39.0 to 50.0
|
—
|
|
Neurocognitive Function
Baseline Working Memory
|
38.5 T scores
Interval 38.0 to 39.0
|
—
|
|
Neurocognitive Function
Baseline Verbal Learning
|
54 T scores
Interval 45.0 to 63.0
|
—
|
|
Neurocognitive Function
Baseline Visual Learning
|
50.5 T scores
Interval 50.0 to 51.0
|
—
|
|
Neurocognitive Function
Baseline Reasoning/Problem Solving
|
52.5 T scores
Interval 52.0 to 53.0
|
—
|
|
Neurocognitive Function
Baseline Social Cognition
|
48 T scores
Interval 44.0 to 52.0
|
—
|
|
Neurocognitive Function
Baseline Overall Composite Score
|
46.5 T scores
Interval 45.0 to 48.0
|
—
|
|
Neurocognitive Function
Week 8 of open-label DCS Processing Speed
|
52.5 T scores
Interval 51.0 to 54.0
|
—
|
|
Neurocognitive Function
Week 8 of open-label DCS Attention/Vigilance
|
47.5 T scores
Interval 39.0 to 56.0
|
—
|
|
Neurocognitive Function
Week 8 of open-label DCS Working Memory
|
50.5 T scores
Interval 49.0 to 52.0
|
—
|
|
Neurocognitive Function
Week 8 of open-label DCS Verbal Learning
|
43.5 T scores
Interval 42.0 to 45.0
|
—
|
|
Neurocognitive Function
Week 8 of open-label DCS Visual Learning
|
54.5 T scores
Interval 51.0 to 58.0
|
—
|
|
Neurocognitive Function
Week 8 of open-label DCS Reasoning/Problem Solving
|
66.5 T scores
Interval 65.0 to 68.0
|
—
|
|
Neurocognitive Function
Week 8 of open-label DCS Social Cognition
|
44.5 T scores
Interval 42.0 to 47.0
|
—
|
|
Neurocognitive Function
Week 8 of open-label DCS Overall Composite Score
|
51.5 T scores
Interval 49.0 to 54.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8 of DCS treatmentPopulation: Data collected only during only one of the open label periods for financial and logistical reasons. Data were collected in week 8 of the first open-label DCS exposure in one subject and in week 8 of the second open-label DCS exposure in the other subject for logistical reasons.
Proton magnetic resonance spectroscopy at 4T: brain glycine/CR ratio. Participants were assessed at baseline (pre-glycine challenge dose and 60, 80, 100 and 120 minutes post glycine dose) and in week 8 of of open-label DCS treatment: pre-DCS dose, and 60, 80, 100 and 120 minutes post DCS dose. Measured in posterior occipital cortex.
Outcome measures
| Measure |
First Open Label DCS
n=2 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Brain Glycine/CR Ratio
Baseline
|
0.41245 ratio
Interval 0.2558 to 0.5691
|
—
|
|
Brain Glycine/CR Ratio
Baseline at 60 minutes
|
0.50375 ratio
Interval 0.3918 to 0.6157
|
—
|
|
Brain Glycine/CR Ratio
Baseline at 80 minutes
|
0.65295 ratio
Interval 0.6428 to 0.6631
|
—
|
|
Brain Glycine/CR Ratio
Baseline at 100 minutes
|
0.61505 ratio
Interval 0.5938 to 0.6363
|
—
|
|
Brain Glycine/CR Ratio
Baseline at 120 minutes
|
0.8256 ratio
Interval 0.6953 to 0.9559
|
—
|
|
Brain Glycine/CR Ratio
Week 8 of DCS: Baseline
|
0.10977 ratio
Interval 0.00007 to 0.21947
|
—
|
|
Brain Glycine/CR Ratio
Week 8 of DCS: 60 minutes
|
0.248885 ratio
Interval 0.24294 to 0.25483
|
—
|
|
Brain Glycine/CR Ratio
Week 8 of DCS: 80 minutes
|
0.32609 ratio
Interval 0.24571 to 0.40647
|
—
|
|
Brain Glycine/CR Ratio
Week 8 of DCS: 100 minutes
|
0.32052 ratio
Interval 0.24289 to 0.39815
|
—
|
|
Brain Glycine/CR Ratio
Week 8 of DCS: 120 minutes
|
0.312155 ratio
Interval 0.1903 to 0.43401
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8 of DCS treatmentPopulation: Only one subject had normal hearing, which is required for valid data collection.
Auditory evoked potential latency: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz.
Outcome measures
| Measure |
First Open Label DCS
n=1 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Auditory Evoked Potentials in Latency (Msec)
P300 at fz: Baseline
|
279.297 msec
|
—
|
|
Auditory Evoked Potentials in Latency (Msec)
P300 at cz: Baseline
|
279.297 msec
|
—
|
|
Auditory Evoked Potentials in Latency (Msec)
P300 at pz: Baseline
|
279.297 msec
|
—
|
|
Auditory Evoked Potentials in Latency (Msec)
N100 at fz: Baseline
|
97.656 msec
|
—
|
|
Auditory Evoked Potentials in Latency (Msec)
N100 at cz: Baseline
|
91.797 msec
|
—
|
|
Auditory Evoked Potentials in Latency (Msec)
P200 at fz: Baseline
|
197.266 msec
|
—
|
|
Auditory Evoked Potentials in Latency (Msec)
P200 at cz: Baseline
|
193.359 msec
|
—
|
|
Auditory Evoked Potentials in Latency (Msec)
P300 at fz: Week 8 of DCS
|
294.920 msec
|
—
|
|
Auditory Evoked Potentials in Latency (Msec)
P300 at cz: Week 8 of DCS
|
294.000 msec
|
—
|
|
Auditory Evoked Potentials in Latency (Msec)
P300 at pz: Week 8 of DCS
|
294 msec
|
—
|
|
Auditory Evoked Potentials in Latency (Msec)
N100 at fz: Week 8 of DCS
|
87.9 msec
|
—
|
|
Auditory Evoked Potentials in Latency (Msec)
N100 at cz: Week 8 of DCS
|
88.000 msec
|
—
|
|
Auditory Evoked Potentials in Latency (Msec)
P200 at fz: Week 8 of DCS
|
212.890 msec
|
—
|
|
Auditory Evoked Potentials in Latency (Msec)
P200 at cz: Week 8 of DCS
|
212.000 msec
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8 of DCS treatmentPopulation: Only one subject had normal hearing, which is required for valid data collection.
Auditory evoked potential amplitude: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz; P50 S1 and S2; mismatch negativity (MMN) at fz and cz.
Outcome measures
| Measure |
First Open Label DCS
n=1 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P300 at fz: Baseline
|
-0.635 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P300 at cz: Baseline
|
6.529 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P300 at pz: Baseline
|
5.340 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
N100 at fz: Baseline
|
-3.926 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
N100 at cz: Baseline
|
-3.615 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P200 at fz: Baseline
|
1.662 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P200 at cz: Baseline
|
6.591 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P50 S1: Baseline
|
2.759 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P50 S2: Baseline
|
1.23 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
MMN at fz: Baseline
|
-3.356 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
MMN at cz: Baseline
|
-4.130 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P300 at fz: Week 8 of DCS
|
3.030 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P300 at cz: Week 8 of DCS
|
6.810 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P300 at pz: Week 8 of DCS
|
6.620 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
N100 at fz: Week 8 of DCS
|
-3.260 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
N100 at cz: Week 8 of DCS
|
-3.940 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P200 at fz: Week 8 of DCS
|
8.200 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P200 at cz: Week 8 of DCS
|
8.160 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P50 S1: Week 8 of DCS
|
1.36 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
P50 S2: Week 8 of DCS
|
0.4 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
MMN at fz: Week 8 of DCS
|
-3.330 microvolts
|
—
|
|
Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
MMN at cz: Week 8 of DCS
|
-1.540 microvolts
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 8 of DCS treatmentPopulation: Only one subject had normal hearing, which is required for valid data collection.
Auditory evoked potential gamma: G40 hz phase locking at fz and cz; G30 hz phase locking at fz and cz; G20 hz phase locking at fz and cz
Outcome measures
| Measure |
First Open Label DCS
n=1 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
|
Second Open Label DCS
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
|
|---|---|---|
|
Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)
G40 hz phase locking at fz: Baseline
|
0.135 microvolts squared
|
—
|
|
Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)
G40 hz phase locking at cz: Baseline
|
0.168 microvolts squared
|
—
|
|
Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)
G30 hz phase locking at fz: Baseline
|
0.190 microvolts squared
|
—
|
|
Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)
G30 hz phase locking at cz: Baseline
|
0.163 microvolts squared
|
—
|
|
Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)
G20 hz phase locking at fz: Baseline
|
0.023 microvolts squared
|
—
|
|
Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)
G20 hz phase locking at cz: Baseline
|
0.030 microvolts squared
|
—
|
|
Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)
G40 hz phase locking at fz: Week 8 of DCS
|
0.344 microvolts squared
|
—
|
|
Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)
G40 hz phase locking at cz: Week 8 of DCS
|
0.381 microvolts squared
|
—
|
|
Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)
G30 hz phase locking at fz: Week 8 of DCS
|
0.168 microvolts squared
|
—
|
|
Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)
G30 hz phase locking at cz: Week 8 of DCS
|
0.19 microvolts squared
|
—
|
|
Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)
G20 hz phase locking at fz: Week 8 of DCS
|
0.01 microvolts squared
|
—
|
|
Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)
G20 hz phase locking at cz: Week 8 of DCS
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-0.01 microvolts squared
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—
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SECONDARY outcome
Timeframe: Baseline and Week 8 of DCS treatmentPopulation: Only one subject had normal hearing, which is required for valid data collection.
Auditory evoked potential amplitude: P50 ratio (P50 S2/S1)
Outcome measures
| Measure |
First Open Label DCS
n=1 Participants
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
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Second Open Label DCS
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
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|---|---|---|
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Auditory Evoked Potentials - P50 Ratio (P50 S2/S1) (Amplitude)
P50 ratio: Baseline
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44.51 ratio
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—
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Auditory Evoked Potentials - P50 Ratio (P50 S2/S1) (Amplitude)
P50 ratio: Week 8 of DCS
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30 ratio
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—
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Adverse Events
Open Label DCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DCS (Crossover)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PLACEBO (CROSSOVER)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Second Open Label DCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place