Schizophrenia Clinical Trial
Official title:
Characterization of Tachyphylaxis, Tolerance, and Withdrawal After Discontinuation of Igalmi in Frequently Agitated Schizophrenic or Bipolar Patients After 7 Days of PRN Treatment
Verified date | December 2023 |
Source | BioXcel Therapeutics Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
Status | Completed |
Enrollment | 23 |
Est. completion date | April 29, 2024 |
Est. primary completion date | April 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Male and female subjects between the ages of 18 to 65 years, inclusive. 2. Subjects who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder or bipolar I or II disorder. 3. Subjects who are currently moderate to severely agitated at least 3 days a week. 4. Subjects who read, understand, and provide written informed consent. 5. Subjects who are in good general health prior to study participation as determined by a detailed medical history and in the opinion of the Principal Investigator. 6. Subjects who agree to use a medically acceptable and effective birth control method 7. Subjects must be willing to remain in-clinic for the duration of the study. Exclusion Criteria: 1. Subjects with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse during screening. 2. Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 6 hours before study treatment. 3. Subjects with congenital prolonged QT syndrome. 4. Prior treatment with Igalmi |
Country | Name | City | State |
---|---|---|---|
United States | BioXcel Clinical Research Site | Little Rock | Arkansas |
United States | BioXcel Clinical Research Site | Rogers | Arkansas |
Lead Sponsor | Collaborator |
---|---|
BioXcel Therapeutics Inc | Lotus Clinical Research, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score | The Positive and Negative Syndrome Scale-Excited Component (PEC) includes 5 items-poor impulse control, tension, hostility, uncooperativeness, and excitement-each of which is rated from 1 (minimum) to 7 (maximum); the sum of these 5 items, the PEC total score, ranges from 5 (absence of agitation) to 35 (extremely severe). | Baseline and 2 hours post-dose for all doses administered | |
Primary | Clinical Global Impression - Improvement (CGI-I) | The Clinical Global Impression - Improvement (CGI-I) for agitation in response to treatment measures the current level of agitation relative to the level of agitation prior to administration of study intervention. The CGI-I scores range from 1 to 7 with a score of 1 indicating very much improved, and a score of 7 indicating very much worse. | 2 hours post-dose for all doses administered | |
Secondary | Incidence of Adverse Events During the Follow-up Period | Evaluation of withdrawal phenomenon based on the occurrence of adverse events such as tachycardia, systolic hypertension, nausea, or vomiting and the emergence of any new adverse events on =2 consecutive days of the 3-day off-treatment follow-up period. | Day 8 through Day 10 |
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