Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| United States Department of Defense | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effectiveness of D-cycloserine for improving social impairment in child with pervasive developmental disorders (PDD).
This study will evaluate the efficacy of D-Cycloserine given 30 minutes prior to each of 10 weekly Social Skills Training Sessions for the treatment of social impairment in children (ages 5-11 years) with PDD during a randomized placebo-controlled trial. This will examine our central hypothesis that D-cycloserine will enhance learning of social skills in children with PDD's.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-cycloserine | Experimental | Subjects randomized to D-cycloserine will be administered 50 mg 30 minutes prior to each of ten Social Skills Training Sessions |
|
| Placebo | Placebo Comparator | Subjects randomized to placebo arm will receive placebo pill 30 minutes prior to each of ten Social Skills Training Sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-cycloserine | Drug | 50 mg dose administered 30 minutes prior to each of the ten Social Skill Training Sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Social Responsiveness Scale (SRS) Change | 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 | Completed at Baseline and Week 11 |
| Social Responsiveness Scale (SRS) at Follow-Up | 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 | Completed at Week 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions Improvement Scale Responder Analysis | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Noha F. Minshawi, Ph.D. | Indiana University | Principal Investigator |
| Craig A. Erickson, M.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States | ||
| Cincinnati Children's Hospital Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37811711 | Derived | Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2. | |
| 33583058 | Derived | Aye SZ, Ni H, Sein HH, Mon ST, Zheng Q, Wong YKY. The effectiveness and adverse effects of D-cycloserine compared with placebo on social and communication skills in individuals with autism spectrum disorder. Cochrane Database Syst Rev. 2021 Feb 14;2(2):CD013457. doi: 10.1002/14651858.CD013457.pub2. |
Not provided
Not provided
One subject with ASD was excluded from analyses due to early dropout prior to taking the study drug.
Participants were recruited from academic autism treatment centers, local schools, and community organizations.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | D-cycloserine | Subjects who received d-cycloserine |
| FG001 | Placebo | Subjects who received placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | D-cycloserine | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Social Responsiveness Scale (SRS) Change | 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 | Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group. | Posted | Mean | Standard Deviation | units on a scale | Completed at Baseline and Week 11 |
|
Data collected at each visit
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D-cycloserine | Subjects who received d-cycloserine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal comment | Psychiatric disorders | Non-systematic Assessment | One instance of making a suicidal comment at school when angry. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Minshawi | Christian Sarkine Autism Treatment Center | 317-944-8162 | nminshaw@iupui.edu |
Not provided
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D020817 | Asperger Syndrome |
| D002659 | Child Development Disorders, Pervasive |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D003523 | Cycloserine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo pill administered 30 minutes prior to each of the ten Social Skill Training Sessions |
|
|
| Week 11 |
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| 28138381 | Derived | Wink LK, Minshawi NF, Shaffer RC, Plawecki MH, Posey DJ, Horn PS, Adams R, Pedapati EV, Schaefer TL, McDougle CJ, Swiezy NB, Erickson CA. d-Cycloserine enhances durability of social skills training in autism spectrum disorder. Mol Autism. 2017 Jan 25;8:2. doi: 10.1186/s13229-017-0116-1. eCollection 2017. |
| 26770664 | Derived | Minshawi NF, Wink LK, Shaffer R, Plawecki MH, Posey DJ, Liu H, Hurwitz S, McDougle CJ, Swiezy NB, Erickson CA. A randomized, placebo-controlled trial of D-cycloserine for the enhancement of social skills training in autism spectrum disorders. Mol Autism. 2016 Jan 14;7:2. doi: 10.1186/s13229-015-0062-8. eCollection 2016. |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects who received placebo |
|
|
|
| Secondary | Clinical Global Impressions Improvement Scale Responder Analysis | 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. | Each social skills group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group. | Posted | Number | percentage of participants | Week 11 |
|
|
|
|
| Primary | Social Responsiveness Scale (SRS) at Follow-Up | 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 | Each group included up to four children with ASD and two typically-developing peer models (TPs) in the same age group. | Posted | Mean | Standard Deviation | units on a scale | Completed at Week 22 |
|
|
|
|
| 0 |
| 34 |
| 32 |
| 34 |
| EG001 | Placebo | Subjects who received placebo | 1 | 33 | 28 | 33 |
|
| Nasal congestion or Cold | General disorders | Non-systematic Assessment |
|
| Cough | General disorders | Non-systematic Assessment |
|
| Vomiting | General disorders | Non-systematic Assessment |
|
| Aggression | Psychiatric disorders | Non-systematic Assessment |
|
| Increased Motor Activity | General disorders | Non-systematic Assessment |
|
| Interrupted Sleep/Other sleep problems | General disorders | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | Non-systematic Assessment |
|
| Restlessness/Agitation | General disorders | Non-systematic Assessment |
|
| Sadness | Psychiatric disorders | Non-systematic Assessment |
|
| Sedation/Drowsiness | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002241 | Carbohydrates |