EUCTR2018-001064-30-BG
Active, not recruiting
Phase 1
A Phase 1, Open Label, Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Pimavanserin in Adolescents with Psychiatric Disorders
ConditionsPsychiatric DisordersMedDRA version: 20.0Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: HLTClassification code 10037177Term: Infancy, childhood and adolescence psychiatric disorders NECSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Psychiatric Disorders
- Sponsor
- ACADIA Pharmaceuticals Inc.
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Study Population
- •1\. Male or female subjects between the ages of \=13 and \<18 years (Note: subjects must be \<18 years by the end of the study)
- •2\. Is within the 5th to 95th percentile for gender specific weight for\-age and height\-for\-age Growth Charts from the National Center for Health Statistics
- •3\. Is able to understand and provide signed informed assent, (informed consent if emancipated) and have a legal guardian who is able to provide signed informed consent
- •4\. Where applicable, has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures
- •5\. In the Investigator’s opinion, the subject and parent/legal guardian are able to understand the nature of the trial, follow protocol requirements (including any inpatient stays required by the Investigator based on the subject’s clinical status), and be willing to comply with study drug administration requirements
- •Psychiatric Diagnosis and Concomitant Medications
- •6\. Has a diagnosis of schizophrenia based on Diagnostic and Statistical Manual\-5 \[DSM\-5]
- •7\. Is judged by the Investigator to be both clinically stable (i.e., no psychiatric hospitalization within the past 12 weeks of Screening) and is not at imminent risk of suicide or injury to self, others, or property
- •8\. Is on a standard of care psychotropic medication for their psychiatric condition
Exclusion Criteria
- •1\. Requires treatment with a medication prohibited by the protocol
- •2\. Is taking more than 2 psychotropic medications at Screening
- •3\. Has a history of mental retardation or persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure or drug induced seizure is not exclusionary.
- •4\. Is at a significant risk of suicide, or is a danger to self or others, in the opinion of the Investigator based upon all available sources of information including C\-SSRS at Screening or Baseline and including more than one life\-threatening suicide attempt
- •5\. Has a significant risk of violent behavior
- •6\. Has a positive urine drug or alcohol test at Screening or positive urine drug dipstick or breathalyzer alcohol test result at Baseline
- •7\. Has met DSM\-5 criteria for substance use disorders within the last 6 months prior to Baseline
- •8\. Consumes either more than 21 units of alcohol per week or 4 units of alcohol per day; 1 unit of alcohol is equivalent to 236 mL of beer, 118 mL of wine, or 130 mL of spirits
- •9\. Excessive use of nicotine\-containing products within 30 days before study drug administration or is using or has used topical or oral nicotine preparations for smoking cessation within the past 30 days before study drug administration
- •10\. Consumes greater than 500 mg of caffeine or xanthine\-containing products per day
Outcomes
Primary Outcomes
Not specified
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