Trial · NCT00965419
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study | Baseline Through Week 252 | Percentage of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Primary | Number of Participants With At Least One SAE | Baseline Through Week 252 | Number of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline Through Week 252 | Percentage of Participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Secondary | Number of Participants With At Least One TEAE | Baseline Through Week 252 | Number of participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Secondary | Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs) | Baseline Through Week 252 | |
| Secondary | Number of Participants With At Least One DCAEs | Baseline Through Week 252 | |
| Secondary | Percentage of Participants Who Discontinued Due to Any Reason | Baseline Through Week 252 | |
| Secondary | Number of Participants Who Discontinued Due to Any Reason | Baseline Through Week 252 | |
| Secondary | Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category | Baseline Through Week 252, Baseline, 1-month (mo) Follow-Up (f/u) | Percentage of Participants in each category of CSSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Participants with suicidal ideation were those who had yes to any of the following questions: Wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior included those who had yes to any of the following questions: Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide. |
| Secondary | Mean Change From Baseline Z-scores for Height | Baseline, Week 60; Baseline, Week 240 | A z-score is the number of standard deviations a data point is from the mean. Z-scores range from -3 standard deviations (far left of the mean in normal distribution curve) up to +3 standard deviations (far right of the mean in normal distribution curve). |
| Secondary | Mean Change From Baseline Z-Score for Weight | Baseline, Week 60; Baseline, Week 240 | A z-score is the number of standard deviations a data point is from the mean. Z-scores range from -3 standard deviations (far left of the mean in normal distribution curve) up to +3 standard deviations (far right of the mean in normal distribution curve). |
| Secondary | Mean Change From Baseline Z-Score in Body Mass Index (BMI) | Baseline, Week 60; Baseline, Week 240 | |
| Secondary | Percentage of Participants With Response Rates | Week 12 | |
| Secondary | Number of Participants With a Response Rate | Week 12 | |
| Secondary | Survival Curve Time to Response | Week 12 | |
| Secondary | Percentage of Participants in Sexual Maturation on Tanners Scale | Baseline Up to Week 252 | Participant's stage of sexual maturation were assessed using the Tanner staging measure for determining pubertal development in male and female participants. Tanner staging includes a self-assessment of pubic hair development (both males and females), genital development (males), and breast development (females). Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast. Tanner stages (1-5) were used to characterize physical development in children, adolescents, and adults. The stages were based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger. |
| Secondary | Number of Participants in Sexual Maturation on Tanners Scale | Baseline Up to Week 252 | Participant's stage of sexual maturation were assessed using the Tanner staging measure for determining pubertal development in male and female participants. Tanner staging includes a self-assessment of pubic hair development (both males and females), genital development (males), and breast development (females). Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast. Tanner stages (1-5) were used to characterize physical development in children, adolescents, and adults. The stages were based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger. |
| Secondary | Percentage of Participants With Tobacco, Alcohol and Marijuana Use | Week 60 through Week 252 | |
| Secondary | Number of Participants With Tobacco, Alcohol and Marijuana Use | Week 60 through Week 252 | |
| Secondary | Mean Change From Baseline of Each Score Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) (Hyperactive/Impulsive, Inattentive and Total Score) | Baseline, Week 12; Baseline, Week 60; Baseline, Week 252 | The ADHDRS-IV-Parent scale measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the 18 items and ranges from 0 to 54. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subscale scores ranging from 0 to 27. Higher total and subscale scores are indicative of more severe symptoms. Least-squares (LS) mean change from baseline was adjusted for repeated measure analysis included baseline score and visit time in the model. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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