Trial · NCT02782104
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Study Baseline in Computerized Cognitive Battery Domain Score: Detection Test (DET) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | log10 msec | MEAN |
| PRIMARY | Change From Study Baseline in Computerized Cognitive Battery Domain Score: Identification Test (IDN) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | log10 msec | MEAN |
| PRIMARY | Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Card Learning Test (OCL) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Arcsine (sqrt of percentage of CR) | MEAN |
| PRIMARY | Change From Study Baseline in Computerized Cognitive Battery Domain Score: One Back Test (ONB) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | log10 msec | MEAN |
| PRIMARY | Change From Study Baseline in Computerized Cognitive Battery Domain Score: Groton Maze Learning Test (GMLT) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Number of Errors | MEAN |
| PRIMARY | Change From Study Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | score on a scale | MEAN |
| PRIMARY | Percentage of Participants Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | IND Phase: up to 4 weeks; OP/MA Phase: up to 78 months | All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Heart Rate | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Full analysis set included participants who received at least 1 dose of intranasal study medication in this study. | beats per minute | MEAN |
| PRIMARY | Change From Baseline in Systolic and Diastolic Blood Pressure | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Full analysis set included participants who received at least 1 dose of intranasal study medication in this study. | Millimeters of mercury (mmHg) | MEAN |
| PRIMARY | Change From Baseline in Respiratory Rate | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Full analysis set included participants who received at least 1 dose of intranasal study medication in this study. | breaths per minute | MEAN |
| PRIMARY | Change From Baseline in Blood Oxygen Saturation | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Full analysis set included participants who received at least 1 dose of intranasal study medication in this study. | percentage of SpO2 | MEAN |
| SECONDARY | Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | score on a Scale | MEAN |
| SECONDARY | Change From Baseline in Participant-Reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ-9) Total Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression-severity (CGI-S) Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Sheehan Disability Scale (SDS) Total Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Participant-Reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Valuation Index Score (VAS) | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Full analysis set included who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline as Assessed by EQ 5D-5L: Sum Score | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Full analysis set included all participants who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Participant- Reported Health Related Quality of Life Using the Quality of Life in Depression Scale (QLDS) | IND Phase: Baseline up to 4 weeks; OP/MA Phase: Baseline up to 78 months | Full analysis set included who received at least 1 dose of intranasal study medication in this study. Here, 'N' (number analyzed) signifies number of participants analyzed for this outcome measure. | score on a scale | MEAN |
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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GET https://conductscience.org/api/trials/v1/NCT02782104/outcomes