Phase 2 Autism Spectrum Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are at least 12 years old and no older than 40 years old.
• People aged 18 or over must be willing and able to sign a consent form; for those under 18, a parent or guardian must sign the consent form on their behalf.
• People who have been diagnosed with Autism Spectrum Disorder (ASD) according to recognised diagnostic standards (DSM-5), confirmed by a licensed psychiatrist or psychologist using a specific assessment tool (ADOS-2), either at the screening visit or within the past 12 months.
• People whose repetitive behaviours are rated as moderately severe or above (a score of 4 or higher on a specific clinical scale) by the study psychiatrist or psychologist.
• People with a non-verbal IQ score of 70 or above, as measured by a standard intelligence test used in the study.
• People who are able to speak and understand English well enough to complete study questionnaires and assessments.
• People who live with a parent, primary caregiver, or another adult who spends an average of at least 4 hours per day with them and can complete study questionnaires on their behalf.
• People whose parent, caregiver, or adult informant is also able to speak and understand English.
• People who are able to take the study medication themselves, or who have a parent or caregiver able to give it to them.
• People who are able to swallow the study medication whole with a liquid.
• People (or their legal representative) who are willing to keep their current medications and behavioural therapies unchanged for the entire duration of the study.

Who may not be able to join:

• People whom the study investigator believes would be unable to follow all study requirements.
• People who are employees or family members of the study investigators directly involved in this research.
• People with a history of a severe or unstable psychiatric condition (such as schizophrenia, bipolar disorder, or major depressive disorder) that could affect the study results or pose a safety risk, as determined by the investigator (confirm with trial site for borderline cases involving mild or moderate mood disorders).
• People who have had significant thoughts of suicide in the past 6 months, or a history of suicidal behaviour in the past year, as measured by a specific safety scale used in the study.
• People who have had a substance use disorder within the 6 months before screening, not including caffeine or nicotine-related disorders.
• People who test positive for illicit drugs or cannabis at screening or at the start of the study (those with a valid cannabis prescription may be re-screened if they agree to stop using cannabis for the duration of the study and test negative on a repeat test).
• People who are currently taking a serotonin reuptake inhibitor (a type of antidepressant) or an antipsychotic medication.
• People who have had any change to their psychiatric medications within the past 2 months.
• People who have received electroconvulsive therapy (ECT) within the past 6 months.
• People who have recently started a new form of psychological therapy, or significantly changed the intensity of an existing one, within the 2 months before screening.
• People with a known allergy or sensitivity to the study drug (Pimavanserin) or any of its ingredients.
• People who have taken another investigational (experimental) drug or used an investigational medical device within the past 3 months, or who are currently enrolled in another investigational study.
• People whose body mass index (BMI) is below 17 or above 40 at the time of screening.
• People with a known personal or family history of a heart condition called long QT syndrome, or a family history of sudden death.
• People who have had a heart attack, unstable chest pain, acute heart-related event, or stroke within the past 4 months, or who have certain other significant heart conditions (confirm with trial site for specific heart condition classifications).
• People with a history of a serious reaction involving the nervous system or body temperature regulation known as neuroleptic malignant syndrome or serotonin syndrome.
• People who have had a seizure within the past 12 months (those with a seizure disorder who have been seizure-free for at least 12 months on stable medication may be considered at the investigator's discretion).
• People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study or within 3 months of the last dose of study medication.
• People with a current or recent (within the past 3 months) serious or unstable medical condition affecting the nervous system, heart, lungs, digestive system, kidneys, liver, blood, or other major body systems, as determined by the investigator.
• People with a history of cancer within the past 5 years (certain minor skin cancers or cancers considered fully cured may be exceptions at the investigator's discretion).
• People with a known history of a positive test for hepatitis C virus (HCV) or HIV.
• People whose heart electrical activity (measured by an ECG at screening or baseline) shows certain abnormal readings above specified thresholds (confirm with trial site for exact values).
• People whose thyroid function blood tests at screening show both an abnormal TSH level and an abnormal free T4 level (an abnormal TSH with a normal free T4 may still be eligible — confirm with trial site).
• People with unstable diabetes or a blood sugar control marker (HbA1c) above 8% at screening.
• People with other significant abnormal laboratory test results that, in the investigator's opinion, would make participation unsafe.

Important: Always verify eligibility with the trial site directly before applying.