Post-Partum Depression MedDRA version: 20.0 Level: LLT Classification code 10056393 Term: Postpartum depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: 5-MeO-DMT 6, 12, 18mg, powder in vial for reconstitution
Product Code: GH001
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: 5-Methoxy-N,N-Dimethyltryptamine
CAS N
Sponsors
GH Research Ireland Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Is female and in the age range between 18 and 45 years (inclusive) at screening; • Meets the trial criteria for PPD: • Diagnosis of Major Depressive Disorder without psychotic features, confirmed by the Mini-International Neuropsychiatric Interview (MINI) (v7.0.2), with peri-partum onset that began no earlier than gestation and no later than the first 4 weeks postpartum, and is > 4 weeks postpartum at dosing but =9 months postpartum at screening; • Has a Montgomery–Åsberg Depression Rating Scale (MADRS) total score of equal to or greater than 28 at screening and pre-dose on Day 0; • Has a Young Mania Rating Scale (YMRS) total score less than or equal to 8 at screening and pre dose on Day 0; • Patients of child-bearing potential must agree to remain completely abstinent or use a highly effective , medically accepted contraceptive method for 30 days prior to dosing and for 30 days after GH001 dosing. Patients must have a negative pregnancy test at screening and on the pre-test day (Day -1); • Is willing to delay start of other antidepressant or anxiety medication until after the end of the trial at Day 7 and agrees to keep any psychotherapy unchanged during the trial; • Is willing and able to nominate a trusted caregiver that has shared legal and physical custody of the infant(s) with the patient, is living in the same household and that is available to take full responsibility for the care and attention of their infant(s) for the entirety of the test day (Day 0) and for 7 days post last dose, and that is present at screening, provides contact details and consents to being contacted by study staff during the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Has, based on history, psychiatric assessment, and evaluation of the MINI, a current or prior diagnosis of bipolar disorder, a manic or hypomanic episode, a psychotic disorder, major depressive disorder (MDD) or other mood disorder with psychotic features, obsessive compulsive disorder, PTSD, autism spectrum disorder, borderline personality 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 or second degree relatives with a current or previously diagnosed bipolar disorder, psychotic disorder or MDD or other mood disorder with psychotic features; Current pregnancy resulting in termination, still-birth, pre-term delivery (before week complete gestational week 37), need for intensive care therapy of mother or child, or adoption of child away from patient; • Has clinically significant pre-menstrual syndrome or premenstrual dysphoric disorder that renders the patient unsuitable for the study according to the investigator’s judgment; • Is in the judgment of a trial psychiatrist or registered psychologist, at significant risk for suicide based on history, psychiatric assessment, and evaluation of suicidal ideation and suicidal behaviour based on the Columbia-Suicide Severity Rating Scale (C-SSRS); • Has had an inadequate response to an adequate course of electroconvulsive therapy, vagal nerve stimulation, repetitive transcranial magnetic or electrical stimulation, or deep brain stimulation in the current episode of depression as assessed using the ATHF-SF; • Has abnormal thyroid function at screening; • Patient who has a positive pregnancy test at screening or on the pre-test day (Day -1), is pregnant, or plans to become pregnant during the course of the trial and up to 30 days after GH001 dosing. • Patients with DSM-5 drug or alcohol use disorder within 6 months prior to screening;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the onset and 7-day durability of anti-depressive effects of a single-day individualized dosing regimen of 6 mg, 12 mg and 18 mg of GH001 in adult, female patients with postpartum depression (PPD).;Secondary Objective: •To determine: othe anti-depressive effects; othe anti-anxiety effects; othe safety and tolerability; othe intensity and duration of psychoactive effects PsE; othe impact on cognitive outcomes. of a single-day individualized dosing regimen of 6 mg, 12 mg and 18 mg of GH001 in adult, female patients with PPD. ;Primary end point(s): •The anti-depressive effects of GH001 evaluated by: oChange from baseline in MADRS ;Timepoint(s) of evaluation of this end point: • Prior to first dose on Day 0 (Baseline), • Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The anti-depressive effects of GH001 evaluated by: • The proportion of patients in remission (MADRS=10); • Change from baseline in MADRS ; • The proportion of responders (=50% reduction from baseline in MADRS total score); • Change from baseline in Clinical Global Impression – Severity scale (CGI-S) ; • The anti-anxiety effects of GH001 evaluated by change from baseline in Hamilton Rating Scale for Anxiety (HAM-A) total score; • Exposure of 5-MeO-DMT and bufotenine in blood; The safety and tolerability of GH001 evaluated by: • Reporting of Treatment Emergent Adverse Events (TEAEs); • Clinically significant changes from baseline in ECG, vital signs, safety laboratory assessments and peak flow respirometry; • Assessment of sedation (Modified Observer's Assessment of Alertness and Sedation scale [MOAA/S]); • Change from baseline in Clinician Administered Dissociative States Scale (CADSS); • Assessment of patient discharge readiness using the Clinical Global Assessment of Discharge Readiness (CGADR); • Change from baseline in Brief Psychiatric Rating Scale (BPRS); • Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS); • Change from baseline in Young Mania Rating Scale (YMRS); The PsE experienced by the patients when the PsE has subsided: • PsE assessment using the Peak Experience (PE) scale to assess the achievement of a PE (PE scale total score =75); • Challenging Experience Questionnaire (CEQ); • Mystical Experience Questionnaire (MEQ-30); • Duration of the PsE defined as the time from study drug dosing to the time when the PsE have subsided; The impact on cognitive outcomes as evaluated by: • Psychomotor Vigilance Task; • Auditory Verbal Learning Test; • Spatial Working Memory Task; • Digit Symbol Substitution Task.;Timepoint(s) of evaluation of this end point: • 2 hours after the final study drug dosing on Day 0, and at Day 1 and Day 7; • 2 hours after the final study drug dosing on Day 0, and at Day 1; • 2 hours after | — |
Countries
Netherlands, United Kingdom
Contacts
Public ContactGH Research Project Manager
GH Research Ireland Limited
Outcome results
None listed