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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

38 participants

Primary outcome timeframe

Baseline score vs. Week 8

Results posted on

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

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

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 8

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).

Outcome measures

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 score

Population: 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

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

Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Serious adverse events

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

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

Donald C Goff

Massachusetts General Hopsital

Phone: 617-912-7899

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place