Phase 2 Clinical Trial of GH001 in Bipolar II Disorder
A Phase 2 Clinical Trial of GH001 in Patients with Bipolar II Disorder and a Current Major Depressive Episode
Sponsor: GH Research Ireland Limited
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
The anti-depressive effects of GH001 evaluated by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) assessed at Day 7
Time frame: From Baseline to Day 7
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 psyc…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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