Trial Outcomes & Findings for Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia (NCT NCT00455702)
NCT ID: NCT00455702
Last Updated: 2014-08-07
Results Overview
The change from baseline to week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the subscale total scores. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).
COMPLETED
PHASE4
38 participants
Baseline score vs. Week 8
2014-08-07
Participant Flow
Participants were stable adult outpatients at an urban community mental health center, ages 18-65 years, with a diagnosis of schizophrenia .
Participant milestones
| Measure |
D-cycloserine
50 mg d-cycloserine
|
Placebo
50 mg placebo
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia
Baseline characteristics by cohort
| Measure |
D-cycloserine
n=19 Participants
50 mg d-cycloserine
|
Placebo
n=19 Participants
50 mg placebo
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 9.15 • n=99 Participants
|
48 years
STANDARD_DEVIATION 6.66 • n=107 Participants
|
49.05 years
STANDARD_DEVIATION 7.905 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
19 participants
n=107 Participants
|
38 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline score vs. Week 8The change from baseline to week 8 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the subscale total scores. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).
Outcome measures
| Measure |
D-cycloserine
n=16 Participants
50 mg d-cycloserine
|
Placebo
n=17 Participants
50 mg placebo
|
|---|---|---|
|
Main Outcome Measure: The Change From Baseline to Week 8 on the SANS
|
2.06 Units on a scale
Standard Deviation 5.03
|
-2.11 Units on a scale
Standard Deviation 7.05
|
SECONDARY outcome
Timeframe: Baseline score vs. Week 8 scorePopulation: One participant from the placebo group was removed from this analysis.
The change from baseline to week 8 on the positive symptom sub-scale of the Positive and Negative Syndrome Scale (PANSS). Total PANSS positive symptom sub-scale scores range from 7-49. The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. A score of one on each item 1 absent, 2 is minimal, 3 is mild, 4 is moderate, 5 is moderately severe, 6 is severe, and 7 is extreme. The total score was computed by adding all the items on the sub-scale together. To compute change in scores, week 8 scores were subtracted from baseline scores, resulting in a change score. Higher values equals greater improvement (i.e. week 8 score was lower than baseline score).
Outcome measures
| Measure |
D-cycloserine
n=16 Participants
50 mg d-cycloserine
|
Placebo
n=16 Participants
50 mg placebo
|
|---|---|---|
|
Treatment Effects on the Positive Syndrome Subscale of the PANSS
|
.19 PANSS Positive Subscale Units
Standard Deviation 2.10
|
-.19 PANSS Positive Subscale Units
Standard Deviation 4.65
|
Adverse Events
D-cycloserine
Placebo
Serious adverse events
| Measure |
D-cycloserine
n=19 participants at risk
50 mg d-cycloserine
|
Placebo
n=19 participants at risk
50 mg placebo
|
|---|---|---|
|
Psychiatric disorders
Worsening psychosis due to discontinuation of anti-psychotic
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
Other adverse events
| Measure |
D-cycloserine
n=19 participants at risk
50 mg d-cycloserine
|
Placebo
n=19 participants at risk
50 mg placebo
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Social circumstances
Anxiety
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Chest pain
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Depression
|
5.3%
1/19 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/19
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
General disorders
Fracture (foot)
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Headache
|
10.5%
2/19 • Number of events 2
|
0.00%
0/19
|
|
General disorders
Nausea
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
10.5%
2/19 • Number of events 2
|
10.5%
2/19 • Number of events 2
|
|
General disorders
Vertigo
|
0.00%
0/19
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/19
|
10.5%
2/19 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place