Trial Outcomes & Findings for D-Cycloserine and Social Skills Training in Autism Spectrum Disorders (NCT NCT01086475)

Last Updated: 2016-04-14

Results Overview

The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

68 participants

Primary outcome timeframe

Completed at Baseline and Week 11

Results posted on

2016-04-14

Participant Flow

Participants were recruited from academic autism treatment centers, local schools, and community organizations.

One subject with ASD was excluded from analyses due to early dropout prior to taking the study drug.

Participant milestones

Participant milestones
Measure	D-cycloserine Subjects who received d-cycloserine	Placebo Subjects who received placebo
Overall Study STARTED	34	33
Overall Study COMPLETED	34	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

D-Cycloserine and Social Skills Training in Autism Spectrum Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D-cycloserine n=34 Participants Subjects randomized to D-cycloserine will be administered 50 mg 30 minutes prior to each of ten Social Skills Training Sessions D-cycloserine: 50 mg dose administered 30 minutes prior to each of the ten Social Skill Training Sessions	Placebo n=33 Participants Subjects randomized to placebo arm will receive placebo pill 30 minutes prior to each of ten Social Skills Training Sessions Placebo: Placebo pill administered 30 minutes prior to each of the ten Social Skill Training Sessions	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	8.49 Years STANDARD_DEVIATION 1.88 • n=5 Participants	8.34 Years STANDARD_DEVIATION 1.70 • n=7 Participants	8.41 Years STANDARD_DEVIATION 1.78 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	33 participants n=7 Participants	67 participants n=5 Participants

PRIMARY outcome

Timeframe: Completed at Baseline and Week 11

Population: Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.

Outcome measures

Outcome measures
Measure	D-cycloserine n=34 Participants Subjects who received d-cycloserine	Placebo n=33 Participants Subjects who received placebo
Social Responsiveness Scale (SRS) Change	-13.39 units on a scale Standard Deviation 16.81	-17.00 units on a scale Standard Deviation 21.33

PRIMARY outcome

Timeframe: Completed at Week 22

Population: Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.

Outcome measures

Outcome measures
Measure	D-cycloserine n=34 Participants Subjects who received d-cycloserine	Placebo n=33 Participants Subjects who received placebo
Social Responsiveness Scale (SRS) at Follow-Up	83.5 units on a scale Standard Deviation 2.3	89.2 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Week 11

Population: Each social skills group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group.

The CGI Global Improvement (CGI-I) is a clinician-rate scale designed to take into account all factors to arrive at an assessment of severity and response to treatment, including parent report, parent-rated measures, teacher-rated measures, and clinician-rated measures. The CGI-I is rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) at a single time-point. The CGI-I was completed at each visit, but only at week 11 were those subjects classified as "much" or "very much improved" defined as responders and all other classifications will be regarded as non-responders.

Outcome measures

Outcome measures
Measure	D-cycloserine n=34 Participants Subjects who received d-cycloserine	Placebo n=33 Participants Subjects who received placebo
Clinical Global Impressions Improvement Scale Responder Analysis	32.3 percentage of participants	33.3 percentage of participants

Adverse Events

D-cycloserine

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	D-cycloserine n=34 participants at risk Subjects who received d-cycloserine	Placebo n=33 participants at risk Subjects who received placebo
Psychiatric disorders Suicidal comment	0.00% 0/34 • Data collected at each visit	3.0% 1/33 • Number of events 1 • Data collected at each visit

Other adverse events

Other adverse events
Measure	D-cycloserine n=34 participants at risk Subjects who received d-cycloserine	Placebo n=33 participants at risk Subjects who received placebo
General disorders Headache	26.5% 9/34 • Number of events 9 • Data collected at each visit	21.2% 7/33 • Number of events 7 • Data collected at each visit
General disorders Nasal congestion or Cold	17.6% 6/34 • Number of events 6 • Data collected at each visit	24.2% 8/33 • Number of events 8 • Data collected at each visit
General disorders Cough	20.6% 7/34 • Number of events 7 • Data collected at each visit	21.2% 7/33 • Number of events 7 • Data collected at each visit
General disorders Vomiting	17.6% 6/34 • Number of events 6 • Data collected at each visit	6.1% 2/33 • Number of events 2 • Data collected at each visit
Psychiatric disorders Aggression	5.9% 2/34 • Number of events 2 • Data collected at each visit	15.2% 5/33 • Number of events 5 • Data collected at each visit
General disorders Increased Motor Activity	2.9% 1/34 • Number of events 1 • Data collected at each visit	15.2% 5/33 • Number of events 5 • Data collected at each visit
General disorders Interrupted Sleep/Other sleep problems	8.8% 3/34 • Number of events 3 • Data collected at each visit	15.2% 5/33 • Number of events 5 • Data collected at each visit
Psychiatric disorders Irritability	47.1% 16/34 • Number of events 16 • Data collected at each visit	45.5% 15/33 • Number of events 15 • Data collected at each visit
General disorders Restlessness/Agitation	11.8% 4/34 • Number of events 4 • Data collected at each visit	9.1% 3/33 • Number of events 3 • Data collected at each visit
Psychiatric disorders Sadness	14.7% 5/34 • Number of events 5 • Data collected at each visit	9.1% 3/33 • Number of events 3 • Data collected at each visit
General disorders Sedation/Drowsiness	5.9% 2/34 • Number of events 2 • Data collected at each visit	18.2% 6/33 • Number of events 6 • Data collected at each visit

Additional Information

Dr. Minshawi

Christian Sarkine Autism Treatment Center

Phone: 317-944-8162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place