Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GH Research Ireland Limited
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Is male or female and in the age range between 18 and 64 years (inclusive) at screening
Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at screening
Meets the trial criteria for bipolar II disorder and is experiencing a major depressive episode, as assessed by a trial psychiatrist or registered clinical psychologist
You may not be if
Has bipolar II disorder with rapid cycling (four or more episodes of hypomania or depressive episodes in previous 12-month period)
Has, based on history, psychiatric assessment, and evaluation of the MINI, a current or prior diagnosis of bipolar I disorder, a manic episode, a psychotic disorder, MDD or other mood disorder with psychotic features, obsessive compulsive disorder, PTSD, autism spectrum disorder, borderline personality disorder, schizophrenia, delusional disorder, paranoid personality disorder, schizoaffective disorder, clinically significant intellectual disability, or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to the investigator's judgment
Has one or more first degree relatives with a current or previously diagnosed psychotic disorder, bipolar I disorder or MDD with psychotic features
Has taken prohibited medication or prohibited dietary supplements within the specified timeframe prior to dosing
Has previously experienced a significant adverse reaction to a hallucinogenic or psychedelic drug according to the investigator's judgment
Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters which renders the patient unsuitable for the trial according to the investigator's judgment
Clareo Health | Phase 2 Clinical Trial of GH001 in Bipolar II Disorder
