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Tests treatment safety and results for Generalized Anxiety Disorder (GAD)
Official title Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder
ClinicalTrials.gov ID: NCT06969170
What this study is testing
What is Psilocybin (drug)?
Psilocybin (drug) is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for generalized anxiety disorder (gad).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase 2a clinical trial is designed to evaluate the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD). The study consists of three sequential phases: Screening Phase (up to 4 weeks), Open-label Run-in Phase (4 weeks), Double-blind Treatment Phase (4 weeks) Screening Phase During the Screening Visit, participants will provide informed consent and undergo a comprehensive medical evaluation, including an abbreviated psychiatric assessment, to determine eligibility.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Must provide written informed consent prior to the initiation of any protocol-specific procedures.
- Male and female adults, between 18 and 60 years of age, inclusive.
- Meets DSM-V criteria for a primary diagnosis of GAD at Screening (duration of diagnosis ≥1 year, based on self-report), confirmed using the MINI.
- Clinician-rated GAD-7 score ≥14 at Screening (Visit 1).
- Clinician-rated HAM-A score ≥14 at Screening (Visit1).
You likely can't join if
- Personal history of schizophrenia, bipolar affective disorder, delusional disorder, paranoid disorder, moderate or severe panic disorder, moderate or...
- History or presence of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic...
- Recently initiated non-pharmacological treatment (e.g., Cognitive Behavioral Therapy, psychotherapy) with a psychologist or health care professional...
- Currently taking pharmacological treatment for GAD or depressive symptoms on a daily basis as outlined in Table 2. Patients who discontinue...
- Clinically significant abnormality on ECG, including a QT interval corrected for heart rate (Bazett; QTcB interval) of \>440 milliseconds in males...
- History of allergies to the investigational product or excipients.
See the full eligibility criteria
Who can join
- Must provide written informed consent prior to the initiation of any protocol-specific procedures.
- Male and female adults, between 18 and 60 years of age, inclusive.
- Meets DSM-V criteria for a primary diagnosis of GAD at Screening (duration of diagnosis ≥1 year, based on self-report), confirmed using the MINI.
- Clinician-rated GAD-7 score ≥14 at Screening (Visit 1).
- Clinician-rated HAM-A score ≥14 at Screening (Visit1).
- Females must be non-pregnant and non-lactating and must fulfil at least one of the following:
- Be surgically sterile for a minimum of 6 months (achieved through hysterectomy, oophorectomy, or bilateral salpingectomy; note that tubal ligation is not considered a method of permanent sterilization).
- Post-menopausal for a minimum of 1 year (confirmed by follicle-stimulating hormone test).
- Agree to avoid pregnancy and use a medically acceptable method of contraception with male sexual partners from at least 30 days prior to the study until 30 days after the study has ended (last study procedure).
- Medically acceptable methods of contraception include any of the following:
- Double-barrier methods (e.g., male condom, spermicide with diaphragm or spermicide with cervical cap)
- Oral contraceptives; hormonal patch, implant or injection; or hormonal or non-hormonal intrauterine device. The male partner should use, at all times, a male condom with spermicide, should the female Patient choose to...
- Complete abstinence, should it be in line with the Patient's preferred and usual lifestyle.
- Males who are able to father children must agree to use medically acceptable methods of contraception during the study and for 30 days after the last study drug administration. If a patient's partner should become...
- Using a condom with a female partner of child-bearing potential who is using oral contraceptives; hormonal patch, implant or injection; hormonal or non-hormonal intrauterine device; or diaphragm or cervical cap with...
- Complete abstinence, should it be in line with the patient's preferred and usual lifestyle.
- Males must refrain from sperm donation from clinic admission to at least 30 days after the last dose of study drug.
- Must be able to speak, read, and understand English sufficiently to allow completion of all study assessments.
- Must be willing to comply with the requirements and restrictions of the study.
What rules you out
- 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...
- History or presence of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other disease at Screening, which, in the...
- 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 will be permitted. Patients...
- 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 baseline will...
- 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.
- History of allergies to the investigational product or excipients.
- 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.
- Positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody.
- 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...
- 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...
- 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...
- 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.
- Female patient is pregnant or breastfeeding.
- Patient, in the investigator's opinion, is unsuitable for clinical study participation. Criteria for Randomization into the blinded Treatment Phase 1\. Minimum 50% reduction in GAD-7 score from Open-Label Baseline Visit...
The study team makes the final eligibility decision.
Where it's taking place
- Kingston, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kingston, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.