Testing Psilocybin (drug) against a placebo for generalized anxiety disorder (GAD)

Exclusion

• −History of allergies to the investigational product or excipients.
• −Positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody.
• −Personal history of schizophrenia, bipolar affective disorder, delusional disorder, paranoid disorder, moderate or severe panic disorder, moderate or severe social anxiety disorder, schizoaffective disorder, moderate or severe obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, moderate or severe post-traumatic stress disorder (as assessed by the IES-R), moderate or severe personality disorder (Cluster B and Cluster C only), moderate or severe MDD (as assessed by the MINI and total scores on the MADRS \> 19).
• −History or presence of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other disease at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →, which, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would jeopardize the safety of the patient or the validity of the study results.
• −Recently initiated non-pharmacological treatment (e.g., Cognitive Behavioral Therapy, psychotherapy) with a psychologist or health care professional (i.e., \<4 weeks prior to Screening). Patients who began a stable non-pharmacological treatment regimen \>4 weeks prior to Screening will be permitted. Patients currently stable on treatment will not be permitted to modify or introduce new elements to their existing treatment regimen while enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in the study.
• −Currently taking pharmacological treatment for GAD or depressive symptoms on a daily basis as outlined in Table 2. Patients who discontinue pharmacological treatment within a minimum of 4 weeks or more of baselineBaselineYour starting measurements, taken before treatment begins.Read more → will be permitted to enroll in the study. Sporadic, prn use of anxiolytics will be permitted; however, patients will be required to document all medication use prior to study enrollment (See Section 9.7).
• −Clinically significant abnormality on ECG, including a QT interval corrected for heart rate (Bazett; QTcB interval) of \>440 milliseconds in males and \>460 milliseconds in females.
• −Positive urine drug screen at Screening , inclusive of cannabis use at a rate above 0.5g/day or 3g/week;
• −\- Abstinence commitment clause: Patients who use cannabis at below or up to the frequency/amount listed above may be allowed to participate if they are willing and able to discontinue use for the duration of the study period without experiencing withdrawal symptoms.
• −Has used CNS drugs with perception-altering properties (e.g., ketamine, lysergic acid diethylamide \[LSD\], phencyclidine \[PCP\], 3,4 methylenedioxymethamphetamine \[MDMA\], mescaline, psilocybin, tryptamine derivatives, or ring-substituted amphetamines with perception-altering effects) on more than 1 occasion for therapeutic or non-therapeutic purposes (i.e., for psychoactive effects) within the past 6 months. History of single or episodic use will not be considered exclusionary.
• −History of suicidal ideation in the past 12 months or active/current suicidality, based on C-SSRS results.
• −Is currently using an investigational drug or device or has used such in the 30 days prior to receiving study drug.
• −Patient, in the investigator's opinion, is unsuitable for clinical study participation.
• −Criteria for RandomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → into the Double-BlindDouble-blindNeither you nor the study team knows which group you are in.Read more → Treatment Phase
• −\. Minimum 50% reduction in GAD-7 score from Open-LabelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more → Baseline Visit (Visit 1) to Double-Blind Baseline Visit
• −Female patient is pregnant or breastfeeding.
• −History of seizures, family history of seizures, history of head trauma, history of neurosurgery, or close family history of idiopathic generalized epilepsy or other congenital epilepsies.
• −Current or history of moderate or severe drug or alcohol use disorder (excluding caffeine and nicotine) within the past 2 years, or lifetime history of participation in a drug rehabilitation program (other than treatment for smoking cessation).