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Trial record 21 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine (DCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02304432
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Deborah L. Levy, Mclean Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Schizophrenia
Bipolar Disorder
Interventions Drug: D-cycloserine
Drug: DCS or placebo
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Label DCS Placebo First, Then DCS DCS First, Then Placebo Second Open Label DCS
Hide Arm/Group Description

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.

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.

One of the sequences during the DB period; dose of DCS, freq of admin; length of trial

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.

Period Title: Open Label DCS
Started 2 0 0 0
Completed 2 0 0 0
Not Completed 0 0 0 0
Period Title: Double-Blind DCS Placebo Crossover
Started 0 1 1 0
Completed 0 1 1 0
Not Completed 0 0 0 0
Period Title: Second Open Label DCS
Started 0 0 0 2
Completed 0 0 0 2
Not Completed 0 0 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description

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

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
42
(34 to 62)
[1]
Measure Description: age at beginning of study
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
2
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
 100.0%
1.Primary Outcome
Title Positive and Negative Symptom Scores
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Open Label DCS Second Open Label DCS
Hide Arm/Group Description:
Both participants received first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
Overall Number of Participants Analyzed 2 2
Median (Full Range)
Unit of Measure: units on a scale
Baseline positive
14.5
(12 to 17)
11
(9 to 13)
Baseline negative
14.5
(11 to 18)
14
(11 to 17)
2 weeks positive
10
(9 to 11)
11
(9 to 13)
2 weeks negative
12
(9 to 15)
14
(11 to 17)
4 weeks positive
10.5
(10 to 11)
10.5
(9 to 12)
4 weeks negative
12
(9 to 15)
13.5
(11 to 16)
6 weeks positive
9
(8 to 10)
9
(8 to 10)
6 weeks negative
12
(9 to 15)
13
(11 to 15)
8 weeks positive
9
(8 to 10)
9.5
(8 to 11)
8 weeks negative
12
(9 to 15)
12
(9 to 15)
10 weeks positive
NA [1] 
(NA to NA)
10.5
(10 to 11)
10 weeks negative
NA [1] 
(NA to NA)
13
(11 to 15)
12 weeks positive
NA [1] 
(NA to NA)
11
(9 to 13)
12 weeks negative
NA [1] 
(NA to NA)
12
(9 to 15)
14 weeks positive
NA [1] 
(NA to NA)
10
(8 to 12)
14 weeks negative
NA [1] 
(NA to NA)
12
(9 to 15)
16 weeks positive
NA [1] 
(NA to NA)
10.5
(10 to 11)
16 weeks negative
NA [1] 
(NA to NA)
12
(9 to 15)
18 weeks positive
NA [1] 
(NA to NA)
10.5
(9 to 12)
18 weeks negative
NA [1] 
(NA to NA)
12
(9 to 15)
20 weeks positive
NA [1] 
(NA to NA)
10.5
(9 to 12)
20 weeks negative
NA [1] 
(NA to NA)
12
(9 to 15)
22 weeks positive
NA [1] 
(NA to NA)
9.5
(8 to 11)
22 weeks negative
NA [1] 
(NA to NA)
12
(9 to 15)
24 weeks positive
NA [1] 
(NA to NA)
10
(8 to 12)
24 weeks negative
NA [1] 
(NA to NA)
12
(9 to 15)
[1]
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
2.Primary Outcome
Title Positive and Negative Symptom Scores
Hide Description 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.
Time Frame Baseline, 2, 4, & 6 weeks (crossover periods)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo First, Then DCS DCS First, Then Placebo
Hide Arm/Group Description:

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.

One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: units on a scale
Baseline positive for first intervention 11 10
Baseline negative symptoms for first intervention 9 15
2 weeks positive for first intervention 12 10
2 weeks negative for first intervention 15 15
4 weeks positive for first intervention 11 10
4 weeks negative for first intervention 13 15
6 weeks positive for first intervention 13 10
6 weeks negative for first intervention 13 15
Baseline positive for second intervention 13 15
Baseline negative for second intervention 13 18
2 weeks positive for second intervention 10 15
2 weeks negative for second intervention 11 18
4 weeks positive for second intervention 9 15
4 weeks negative for second intervention 11 18
6 weeks positive for second intervention 9 14
6 weeks negative for second intervention 11 18
3.Primary Outcome
Title Brief Psychiatric Rating Scale (BPRS) Scores
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Open Label DCS Second Open Label DCS
Hide Arm/Group Description:
Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
Overall Number of Participants Analyzed 2 2
Median (Full Range)
Unit of Measure: units on a scale
Baseline BPRS
37
(34 to 40)
31.5
(28 to 35)
2 weeks BPRS
25
(22 to 28)
30.5
(27 to 34)
4 weeks BPRS
26
(24 to 28)
28
(27 to 29)
6 weeks BPRS
24
(22 to 26)
25.5
(25 to 26)
8 weeks BPRS
24.5
(23 to 26)
26
(24 to 28)
10 weeks BPRS
NA [1] 
(NA to NA)
26.5
(26 to 27)
12 weeks BPRS
NA [1] 
(NA to NA)
26
(24 to 28)
14 weeks BPRS
NA [1] 
(NA to NA)
25.5
(24 to 27)
16 weeks BPRS
NA [1] 
(NA to NA)
28.5
(27 to 30)
18 weeks BPRS
NA [1] 
(NA to NA)
27
(25 to 29)
20 weeks BPRS
NA [1] 
(NA to NA)
25
(23 to 27)
22 weeks BPRS
NA [1] 
(NA to NA)
24.5
(22 to 27)
24 weeks BPRS
NA [1] 
(NA to NA)
26.5
(25 to 28)
[1]
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
4.Primary Outcome
Title Brief Psychiatric Rating Scale (BPRS) Scores
Hide Description 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.
Time Frame Baseline, 2, 4, & 6 weeks (crossover periods)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo First, Then DCS DCS First, Then Placebo
Hide Arm/Group Description:

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.

One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: units on a scale
Baseline BPRS for first intervention 29 26
2 weeks BPRS for first intervention 35 25
4 weeks BPRS for first intervention 33 25
6 weeks BPRS for first intervention 35 26
Baseline BPRS for second intervention 36 39
2 weeks BPRS for second intervention 30 45
4 weeks BPRS for second intervention 27 45
6 weeks BPRS for second intervention 28 38
5.Primary Outcome
Title Clinical Global Impression (CGI) Severity Scores
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Open Label DCS Second Open Label DCS
Hide Arm/Group Description:
Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
Both participants received second open label exposures to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
Overall Number of Participants Analyzed 2 2
Median (Full Range)
Unit of Measure: units on a scale
Baseline CGI
4
(4 to 4)
2.5
(2 to 3)
2 weeks CGI
2
(2 to 2)
2.5
(2 to 3)
4 weeks CGI
2
(2 to 2)
2.5
(2 to 3)
6 weeks CGI
2
(2 to 2)
2.5
(2 to 3)
8 weeks CGI
2
(2 to 2)
2.5
(2 to 3)
10 weeks CGI
NA [1] 
(NA to NA)
3
(3 to 3)
12 weeks CGI
NA [1] 
(NA to NA)
2.5
(2 to 3)
14 weeks CGI
NA [1] 
(NA to NA)
2
(2 to 2)
16 weeks CGI
NA [1] 
(NA to NA)
2.5
(2 to 3)
18 weeks CGI
NA [1] 
(NA to NA)
2.5
(2 to 3)
20 weeks CGI
NA [1] 
(NA to NA)
2.5
(2 to 3)
22 weeks CGI
NA [1] 
(NA to NA)
2.5
(2 to 3)
24 weeks CGI
NA [1] 
(NA to NA)
2.5
(2 to 3)
[1]
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
6.Primary Outcome
Title Clinical Global Impression (CGI) Severity Scores
Hide Description 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.
Time Frame Baseline, 2, 4, & 6 weeks (crossover periods)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo First, Then DCS DCS First, Then Placebo
Hide Arm/Group Description:

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.

One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: units on a scale
Baseline CGI for first intervention 1 2
2 weeks CGI for first intervention 3 2
4 weeks CGI for first intervention 3 2
6 weeks CGI for first intervention 3 2
Baseline CGI for second intervention 3 3
2 weeks CGI for second intervention 2 3
4 weeks CGI for second intervention 2 3
6 weeks CGI for second intervention 2 3
7.Primary Outcome
Title Mania Symptom Scores
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Open Label DCS Second Open Label DCS
Hide Arm/Group Description:
Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
Overall Number of Participants Analyzed 2 2
Median (Full Range)
Unit of Measure: units on a scale
Baseline YMRS
2
(2 to 2)
0
(0 to 0)
2 weeks YMRS
1
(0 to 2)
0
(0 to 0)
4 weeks YMRS
1
(0 to 2)
0
(0 to 0)
6 weeks YMRS
0
(0 to 0)
0
(0 to 0)
8 weeks YMRS
0
(0 to 0)
0
(0 to 0)
10 weeks YMRS
NA [1] 
(NA to NA)
0
(0 to 0)
12 weeks YMRS
NA [1] 
(NA to NA)
0
(0 to 0)
14 weeks YMRS
NA [1] 
(NA to NA)
0
(0 to 0)
16 weeks YMRS
NA [1] 
(NA to NA)
0
(0 to 0)
18 weeks YMRS
NA [1] 
(NA to NA)
0
(0 to 0)
20 weeks YMRS
NA [1] 
(NA to NA)
0
(0 to 0)
22 weeks YMRS
NA [1] 
(NA to NA)
0
(0 to 0)
24 weeks YMRS
NA [1] 
(NA to NA)
1
(0 to 2)
[1]
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
8.Primary Outcome
Title Depression Symptom Scores
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title First Open Label DCS Second Open Label DCS
Hide Arm/Group Description:
Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks.
Both participants received second open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks.
Overall Number of Participants Analyzed 2 2
Median (Full Range)
Unit of Measure: units on a scale
Baseline HAM
5
(4 to 6)
0.5
(0 to 1)
2 weeks HAM
1.5
(0 to 3)
1
(1 to 1)
4 weeks HAM
1
(0 to 2)
1
(0 to 2)
6 weeks HAM
0.5
(0 to 1)
0
(0 to 0)
8 weeks HAM
1.5
(0 to 3)
2.5
(0 to 5)
10 weeks HAM
NA [1] 
(NA to NA)
0
(0 to 0)
12 weeks HAM
NA [1] 
(NA to NA)
0
(0 to 0)
14 weeks HAM
NA [1] 
(NA to NA)
0
(0 to 0)
16 weeks HAM
NA [1] 
(NA to NA)
3.5
(0 to 7)
18 weeks HAM
NA [1] 
(NA to NA)
0
(0 to 0)
20 weeks HAM
NA [1] 
(NA to NA)
0
(0 to 0)
22 weeks HAM
NA [1] 
(NA to NA)
0
(0 to 0)
24 weeks HAM
NA [1] 
(NA to NA)
0
(0 to 0)
[1]
This open label period lasted only 8 weeks, so no additional data were collected for this time point.
9.Primary Outcome
Title Mania Symptom Scores
Hide Description 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.
Time Frame Baseline, 2, 4, & 6 weeks (crossover periods)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo First, Then DCS DCS First, Then Placebo
Hide Arm/Group Description:

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.

One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: units on a scale
Baseline YMRS for first intervention 1 0
2 weeks YMRS for first intervention 0 0
4 weeks YMRS for first intervention 0 0
6 weeks YMRS for first intervention 0 0
Baseline YMRS for second intervention 4 0
2 weeks YMRS for second intervention 1 0
4 weeks YMRS for second intervention 1 0
6 weeks YMRS for second intervention 1 0
10.Primary Outcome
Title Depression Symptom Scores
Hide Description 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.
Time Frame Baseline, 2, 4, & 6 weeks (crossover periods)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo First, Then DCS DCS First, Then Placebo
Hide Arm/Group Description:

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.

One of the sequences during the DB period; dose of DCS, freq of admin; length of trial
Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: units on a scale
Baseline HAM for first intervention 4 0
2 weeks HAM for first intervention 5 1
4 weeks HAM for first intervention 2 0
6 weeks HAM for first intervention 10 0
Baseline HAM for second intervention 0 2
2 weeks HAM for second intervention 0 12
4 weeks HAM for second intervention 0 9
6 weeks HAM for second intervention 0 2
11.Secondary Outcome
Title Neurocognitive Function
Hide Description 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.
Time Frame Baseline and Week 8 of open-label DCS treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Open Label DCS
Hide Arm/Group Description:
During the first open label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks. During the second open-label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks. One subject was tested at the beginning of week 8 of the first open-label period and the other subject was tested at the beginning of week 8 of the second open-label period.
Overall Number of Participants Analyzed 2
Median (Full Range)
Unit of Measure: T scores
Baseline Processing Speed
48.5
(43 to 54)
Baseline Attention/Vigilance
44.5
(39 to 50)
Baseline Working Memory
38.5
(38 to 39)
Baseline Verbal Learning
54
(45 to 63)
Baseline Visual Learning
50.5
(50 to 51)
Baseline Reasoning/Problem Solving
52.5
(52 to 53)
Baseline Social Cognition
48
(44 to 52)
Baseline Overall Composite Score
46.5
(45 to 48)
Week 8 of open-label DCS Processing Speed
52.5
(51 to 54)
Week 8 of open-label DCS Attention/Vigilance
47.5
(39 to 56)
Week 8 of open-label DCS Working Memory
50.5
(49 to 52)
Week 8 of open-label DCS Verbal Learning
43.5
(42 to 45)
Week 8 of open-label DCS Visual Learning
54.5
(51 to 58)
Week 8 of open-label DCS Reasoning/Problem Solving
66.5
(65 to 68)
Week 8 of open-label DCS Social Cognition
44.5
(42 to 47)
Week 8 of open-label DCS Overall Composite Score
51.5
(49 to 54)
12.Secondary Outcome
Title Brain Glycine/CR Ratio
Hide Description 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.
Time Frame Baseline and Week 8 of DCS treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Open Label DCS
Hide Arm/Group Description:
During the first open label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks. During the second open-label period, both participants received D-cycloserine (seromycin), 50 mg/d capsule, for 24 weeks. OOne subject was tested at the beginning of week 8 of the first open-label period and the other subject was tested at the beginning of week 8 of the second open-label period.
Overall Number of Participants Analyzed 2
Median (Full Range)
Unit of Measure: ratio
Baseline
0.41245
(0.2558 to 0.5691)
Baseline at 60 minutes
0.50375
(0.3918 to 0.6157)
Baseline at 80 minutes
0.65295
(0.6428 to 0.6631)
Baseline at 100 minutes
0.61505
(0.5938 to 0.6363)
Baseline at 120 minutes
0.8256
(0.6953 to 0.9559)
Week 8 of DCS: Baseline
0.10977
(0.00007 to 0.21947)
Week 8 of DCS: 60 minutes
0.248885
(0.24294 to 0.25483)
Week 8 of DCS: 80 minutes
0.32609
(0.24571 to 0.40647)
Week 8 of DCS: 100 minutes
0.32052
(0.24289 to 0.39815)
Week 8 of DCS: 120 minutes
0.312155
(0.1903 to 0.43401)
13.Secondary Outcome
Title Auditory Evoked Potentials in Latency (Msec)
Hide Description Auditory evoked potential latency: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz.
Time Frame Baseline and Week 8 of DCS treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Only one subject had normal hearing, which is required for valid data collection.
Arm/Group Title First Open Label DCS
Hide Arm/Group Description:
The subject received the first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks and was tested at the beginning of week 8.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: msec
P300 at fz: Baseline 279.297
P300 at cz: Baseline 279.297
P300 at pz: Baseline 279.297
N100 at fz: Baseline 97.656
N100 at cz: Baseline 91.797
P200 at fz: Baseline 197.266
P200 at cz: Baseline 193.359
P300 at fz: Week 8 of DCS 294.920
P300 at cz: Week 8 of DCS 294.000
P300 at pz: Week 8 of DCS 294
N100 at fz: Week 8 of DCS 87.9
N100 at cz: Week 8 of DCS 88.000
P200 at fz: Week 8 of DCS 212.890
P200 at cz: Week 8 of DCS 212.000
14.Secondary Outcome
Title Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)
Hide Description 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.
Time Frame Baseline and Week 8 of DCS treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Only one subject had normal hearing, which is required for valid data collection.
Arm/Group Title First Open Label DCS
Hide Arm/Group Description:
The subject received the first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks and was tested at the beginning of week 8.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: microvolts
P300 at fz: Baseline -0.635
P300 at cz: Baseline 6.529
P300 at pz: Baseline 5.340
N100 at fz: Baseline -3.926
N100 at cz: Baseline -3.615
P200 at fz: Baseline 1.662
P200 at cz: Baseline 6.591
P50 S1: Baseline 2.759
P50 S2: Baseline 1.23
MMN at fz: Baseline -3.356
MMN at cz: Baseline -4.130
P300 at fz: Week 8 of DCS 3.030
P300 at cz: Week 8 of DCS 6.810
P300 at pz: Week 8 of DCS 6.620
N100 at fz: Week 8 of DCS -3.260
N100 at cz: Week 8 of DCS -3.940
P200 at fz: Week 8 of DCS 8.200
P200 at cz: Week 8 of DCS 8.160
P50 S1: Week 8 of DCS 1.36
P50 S2: Week 8 of DCS 0.4
MMN at fz: Week 8 of DCS -3.330
MMN at cz: Week 8 of DCS -1.540
15.Secondary Outcome
Title Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)
Hide Description 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
Time Frame Baseline and Week 8 of DCS treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Only one subject had normal hearing, which is required for valid data collection.
Arm/Group Title First Open Label DCS
Hide Arm/Group Description:
The subject received the first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks and was tested at the beginning of week 8.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: microvolts squared
G40 hz phase locking at fz: Baseline 0.135
G40 hz phase locking at cz: Baseline 0.168
G30 hz phase locking at fz: Baseline 0.190
G30 hz phase locking at cz: Baseline 0.163
G20 hz phase locking at fz: Baseline 0.023
G20 hz phase locking at cz: Baseline 0.030
G40 hz phase locking at fz: Week 8 of DCS 0.344
G40 hz phase locking at cz: Week 8 of DCS 0.381
G30 hz phase locking at fz: Week 8 of DCS 0.168
G30 hz phase locking at cz: Week 8 of DCS 0.19
G20 hz phase locking at fz: Week 8 of DCS 0.01
G20 hz phase locking at cz: Week 8 of DCS -0.01
16.Secondary Outcome
Title Auditory Evoked Potentials - P50 Ratio (P50 S2/S1) (Amplitude)
Hide Description Auditory evoked potential amplitude: P50 ratio (P50 S2/S1)
Time Frame Baseline and Week 8 of DCS treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Only one subject had normal hearing, which is required for valid data collection.
Arm/Group Title First Open Label DCS
Hide Arm/Group Description:
The subject received the first open label exposure to D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks and was tested at the beginning of week 8.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: ratio
P50 ratio: Baseline 44.51
P50 ratio: Week 8 of DCS 30
Time Frame 48 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label DCS DCS (Crossover) PLACEBO (CROSSOVER) Second Open Label DCS
Hide Arm/Group Description Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 8 weeks. Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, for 6 weeks. Both participants received placebo for 6 weeks.

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.

All-Cause Mortality
Open Label DCS DCS (Crossover) PLACEBO (CROSSOVER) Second Open Label DCS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Open Label DCS DCS (Crossover) PLACEBO (CROSSOVER) Second Open Label DCS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open Label DCS DCS (Crossover) PLACEBO (CROSSOVER) Second Open Label DCS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Deborah Levy
Organization: McLean Hospital
Phone: 617-855-2854
Other Publications:
McCarthy SE, Makarov V, Kirov G, Addington AM, McClellan J, Yoon S, Perkins DO, Dickel DE, Kusenda M, Krastoshevsky O, Krause V, Kumar RA, Grozeva D, Malhotra D, Walsh T, Zackai EH, Kaplan P, Ganesh J, Krantz ID, Spinner NB, Roccanova P, Bhandari A, Pavon K, Lakshmi B, Leotta A, Kendall J, Lee YH, Vacic V, Gary S, Iakoucheva LM, Crow TJ, Christian SL, Lieberman JA, Stroup TS, Lehtimäki T, Puura K, Haldeman-Englert C, Pearl J, Goodell M, Willour VL, Derosse P, Steele J, Kassem L, Wolff J, Chitkara N, McMahon FJ, Malhotra AK, Potash JB, Schulze TG, Nöthen MM, Cichon S, Rietschel M, Leibenluft E, Kustanovich V, Lajonchere CM, Sutcliffe JS, Skuse D, Gill M, Gallagher L, Mendell NR; Wellcome Trust Case Control Consortium, Craddock N, Owen MJ, O'Donovan MC, Shaikh TH, Susser E, Delisi LE, Sullivan PF, Deutsch CK, Rapoport J, Levy DL, King MC, Sebat J. Microduplications of 16p11.2 are associated with schizophrenia. Nat Genet. 2009 Nov;41(11):1223-7. doi: 10.1038/ng.474. Epub 2009 Oct 25.
Responsible Party: Deborah L. Levy, Mclean Hospital
ClinicalTrials.gov Identifier: NCT02304432     History of Changes
Other Study ID Numbers: 1R21MH105732 ( U.S. NIH Grant/Contract )
First Submitted: November 26, 2014
First Posted: December 2, 2014
Results First Submitted: July 31, 2017
Results First Posted: September 19, 2017
Last Update Posted: September 19, 2017