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Trial Outcomes & Findings for Trial of D-Cycloserine in Schizophrenia (NCT NCT00000371)

NCT ID: NCT00000371

Last Updated: 2014-09-10

Results Overview

The slope of SANS total score from baseline to week 8 in the treatment and placebo groups 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 slopes were obtained by plotting the group SANS total score mean for treatment vs. placebo on Baseline, Week 4, and Week 8 and performing a random slopes model.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

Baseline, Week 4, Week 8

Results posted on

2014-09-10

Participant Flow

Subjects were adult outpatients recruited from three urban community health centers and two Veteran's Affairs medical centers in the greater Boston area. All eligible participants at these sites were invited to participate by their clinicians.

Sixty subjects met eligibility criteria and provided informed consent, but just 55 completed baseline assessments and were randomized to d-cycloserine or placebo.

Participant milestones

Participant milestones
Measure
D-Cycloserine
Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
Placebo
Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
Overall Study
STARTED
27
28
Overall Study
COMPLETED
14
12
Overall Study
NOT COMPLETED
13
16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of D-Cycloserine in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
D-Cycloserine
n=27 Participants
Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
Placebo
n=28 Participants
Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
Total
n=55 Participants
Total of all reporting groups
Age, Continuous
45.9 Years
STANDARD_DEVIATION 7.4 • n=5 Participants
47.0 Years
STANDARD_DEVIATION 8.6 • n=7 Participants
46.5 Years
STANDARD_DEVIATION 8.0 • n=5 Participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
27 Participants
n=5 Participants
28 Participants
n=7 Participants
55 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
8 Participants
n=7 Participants
11 Participants
n=5 Participants
Sex: Female, Male
Male
24 Participants
n=5 Participants
20 Participants
n=7 Participants
44 Participants
n=5 Participants
Region of Enrollment
United States
27 participants
n=5 Participants
28 participants
n=7 Participants
55 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4, Week 8

The slope of SANS total score from baseline to week 8 in the treatment and placebo groups 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 slopes were obtained by plotting the group SANS total score mean for treatment vs. placebo on Baseline, Week 4, and Week 8 and performing a random slopes model.

Outcome measures

Outcome measures
Measure
D-Cycloserine
n=28 Participants
Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
Placebo
n=27 Participants
Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
Scale for the Assessment of Negative Symptoms (SANS)
-.46 units on a scale/weeks
Standard Error .29
-.41 units on a scale/weeks
Standard Error .31

Adverse Events

D-Cycloserine

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

Placebo

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

Dr. Donald Goff

Freedom Clinic Trail, Massachusetts General Hospital

Phone: 617-921-7899

Results disclosure agreements

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