Trial · NCT05030129
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Tolerability - Number of Treatment-Emergent Adverse Events | Baseline through Week 17 | The Safety population will include all participants who received at least one dose of study treatment. | Number of Adverse Events | NUMBER |
| PRIMARY | Safety and Tolerability - Severity of Treatment Emergent Adverse Events | Baseline through Week 17 | The Safety population will include all participants who received at least one dose of study treatment. | Number of Adverse Events | NUMBER |
| SECONDARY | Change From Baseline in KiTAP Executive Battery - Alertness Subscore (Reaction Time) | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit. | milliseconds | MEAN |
| SECONDARY | Change From Baseline in Total Number of Correct Responses on KiTAP Executive Battery Distractibility Subtest | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which includes all participants who received at least one dose of treatment and returned for at least one follow-up visit. | Correct Responses | MEAN |
| SECONDARY | Change From Baseline in Total Number of Errors on KiTAP Executive Battery Distractibility Subtest | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which includes all participants who received at least one dose of treatment and returned for at least one follow-up visit. | Errors | MEAN |
| SECONDARY | Change From Baseline in Total Number of Correct Responses on KiTAP Executive Battery Flexibility Subtest | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit. | Correct Responses | MEAN |
| SECONDARY | Change From Baseline in Total Number of Errors on KiTAP Executive Battery Flexibility Subtest | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit. | Errors | MEAN |
| SECONDARY | Change From Baseline in Total Number of Correct Responses on KiTAP Test of Attentional Performance Go-NoGo Subtest | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | The primary efficacy population will be the intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit. | Correct Responses | MEAN |
| SECONDARY | Change From Baseline in Total Number of Errors on KiTAP Test of Attentional Performance Go-NoGo Subtest | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | The primary efficacy population will be the intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit. | Errors | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression Severity Scale Overall Score | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Aberrant Behavior Checklist (ABC) Subscores | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Anxiety, Depression, and Mood Scale (ADAMS) Subscores | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit. | score on a scale | MEAN |
| SECONDARY | Change From Baseline on Vineland-3 Adaptive Behavior Scale - Subdomain Growth Scale Values | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in NIH Toolbox Cognitive Battery for Intellectual Disabilities (NIH-TCB) Total Cognition Score | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which includes all participants who received at least one dose of treatment and returned for at least one follow-up visit. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Visual Analog Scale (VAS) Assessment Domain Scores | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit. | score on a scale | MEAN |
| SECONDARY | Event-Related Potentials (ERP) - Gamma Band Absolute Power at Resting State (Frontal) | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit. | V^2/Hz | MEAN |
| SECONDARY | Event-Related Potentials (ERP) Components in Response to Standard Tones | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit. | μV*seconds | MEAN |
| SECONDARY | Event-Related Potentials - Frontal Alpha Asymmetry at Resting State | Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment) | Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit. | unitless | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05030129/outcomes