Trial · NCT02497287
Outcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to End of Follow up Phase (Week 56) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders | Up to End of Follow up Phase (Week 56) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. | Percentage of participants | NUMBER |
| PRIMARY | Change From Baseline in Cognitive Test Battery: Detection Test (DET) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of Optimization/Maintenance [OP/MA] Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | log10 msec | MEAN |
| PRIMARY | Change From Baseline in Cognitive Test Battery: Identification Test (IDN) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | log10 msec | MEAN |
| PRIMARY | Change From Baseline in Cognitive Test Battery: One Card Learning Test (OCL) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Arcsine ([sqrt] of proportion of [CR]) | MEAN |
| PRIMARY | Change From Baseline in Cognitive Test Battery: One Back Test (ONB) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | log10 msec | MEAN |
| PRIMARY | Change From Baseline in Cognitive Test Battery: Groton Maze Learning Test (GMLT) Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Number of Errors | MEAN |
| PRIMARY | Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Total Recall | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Number correct | MEAN |
| PRIMARY | Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Delayed Recall | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Number correct | MEAN |
| PRIMARY | Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Number of Words Recalled | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Number of words recalled | MEAN |
| PRIMARY | Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Recognition Discrimination Index | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase) | All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Number of words | MEAN |
| SECONDARY | Change From Baseline to Endpoint in Montgomery Asberg Depression Rating Scale (MADRS) Total Score During Induction (IND) Phase | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase) | The full (IND) analysis set included all participants who received at least 1 dose of intranasal study medication or 1 dose of oral AD in open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline to Endpoint in MADRS Total Score During Optimization/Maintenance (OP/MA) Phase | Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase) | Full (OP/MA) analysis set: All participants who received at least 1 dose of intranasal study medication or 1 dose of oral AD in the OP/MA phase. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline to Endpoint in Patient Health Questionnaire - 9 (PHQ-9) Total Score During IND Phase | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase) | Full (IND) analysis set: All participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Unit on a Scale | MEAN |
| SECONDARY | Change From Baseline to Endpoint in PHQ-9 Total Score During OP/MA Phase | Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase) | Full (OP/MA) analysis set: All participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the OP/MA phase. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline to Endpoint in Clinical Global Impression of Severity (CGI-S) Scale Score During IND Phase | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase) | Full (IND) analysis set: All participants who received at least 1 dose of intranasal study medication or 1 dose of oral AD in the open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Units on a Scale | MEDIAN |
| SECONDARY | Change From Baseline to Endpoint in CGI-S Scale Score During OP/MA Phase | Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase) | The full (OP/MA) analysis set included all participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the OP/MA phase. | Units on a Scale | MEDIAN |
| SECONDARY | Change From Baseline to Endpoint in Generalized Anxiety Disorder (GAD-7) Total Score During IND Phase | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase) | The full (IND) analysis set included all participants who received at least 1 dose of intranasal study drug or 1 dose of oral AD in the open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline to Endpoint in GAD-7 Total Score During OP/MA Phase | Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase) | Full (OP/MA) analysis set: All participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the OP/MA phase. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During IND Phase: Sum Score | Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase) | The full (IND) analysis set included all participants who received at least 1 dose of intranasal study drug or 1 dose of oral AD in the open-label IND phase (direct-entry, transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Units 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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