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The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with Bipolar I Disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iloperidone | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iloperidone | Drug | Oral iloperidone |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score | The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst). | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Little Rock | Arkansas | 72211 | United States | ||
| Vanda Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38236020 | Derived | Torres R, Czeisler EL, Chadwick SR, Stahl SM, Smieszek SP, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2024 Jan 15;85(1):23m14966. doi: 10.4088/JCP.23m14966. |
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Safety analyses included patients who received 1 or more doses of study medication. Of the 417 randomized, 414 received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iloperidone | Iloperidone: Oral iloperidone |
| FG001 | Placebo | Iloperidone Placebo: Oral placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2021 |
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| Iloperidone Placebo | Drug | Oral placebo |
|
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Vanda Investigational Site | Cerritos | California | 90703 | United States |
| Vanda Investigational Site | Culver City | California | 90230 | United States |
| Vanda Investigational Site | Long Beach | California | 90806 | United States |
| Vanda Investigational Site | Orange | California | 92868 | United States |
| Vanda Investigational Site | Torrance | California | 90502 | United States |
| Vanda Investigational Site | Miami Lakes | Florida | 33016 | United States |
| Vanda Investigational Site | Oakland Park | Florida | 33334 | United States |
| Vanda Investigational Site | Atlanta | Georgia | 30331 | United States |
| Vanda Investigational Site | Decatur | Georgia | 30030 | United States |
| Vanda Investigational Site | Gaithersburg | Maryland | 20877 | United States |
| Vanda Investigational Site | Flowood | Mississippi | 39232 | United States |
| Vanda Investigational Site | Las Vegas | Nevada | 89102 | United States |
| Vanda Investigational Site | Marlton | New Jersey | 08053 | United States |
| Vanda Investigational Site | Dayton | Ohio | 45417 | United States |
| Vanda Investigational Site | North Canton | Ohio | 44720 | United States |
| Vanda Investigational Site | Austin | Texas | 78754 | United States |
| Vanda Investigational Site | DeSoto | Texas | 75115 | United States |
| Vanda Investigational Site | Richardson | Texas | 75080 | United States |
| Vanda Investigational Site | Novi Iskar | Sofia-Grad | 1282 | Bulgaria |
| Vanda Investigational Site | Tserova Koria | Veliko Tarnovo | 5047 | Bulgaria |
| Vanda Investigational Site | Kardzhali | 6600 | Bulgaria |
| Vanda Investigational Site | Lovech | 5500 | Bulgaria |
| Vanda Investigational Site | Veliko Tarnovo | 5000 | Bulgaria |
| Vanda Investigational Site | Vratsa | 3001 | Bulgaria |
| Vanda Investigational Site | Tuszyn | 95-080 | Poland |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Iloperidone | Iloperidone: Oral iloperidone |
| BG001 | Placebo | Iloperidone Placebo: Oral placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score | The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst). | Efficacy analyses were based on the Intent-To-Treat (ITT) population, which included all randomized patients who received a dose of study drug and had at least one valid post-baseline efficacy measurement while on study medication. Of the 417 randomized, 392 received at least one dose of study medication and had at least one valid post-baseline efficacy measurement. | Posted | Mean | Standard Error | Change from Baseline in YMRS Total Score | Week 4 |
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AE data was collected during the 28 day study period plus a 7 day follow up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iloperidone | Iloperidone: Oral iloperidone | 0 | 206 | 4 | 206 | 88 | 206 |
| EG001 | Placebo | Iloperidone Placebo: Oral placebo | 0 | 208 | 1 | 208 | 25 | 208 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Sedation | Nervous system disorders | Systematic Assessment |
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| Spontaneous penile erection | Reproductive system and breast disorders | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bipolar disorder (depression) | Psychiatric disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Weight increased | Investigations | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals | Vanda Pharmaceuticals | 202-734-3400 | clinicaltrials@vandapharma.com |
| Mar 19, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C081732 | iloperidone |
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| Male |
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| Black or African American |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| American Indian or Alaska Native |
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| Other |
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