Exploratory trial to assess the efficacy and safety of Psilocybin-Assisted Psychotherapy (PAP) involving family-members compared to standard PAP, in adults with treatment-resistant major depressive disorder. (TRMDD).
- Conditions
- Treatment-resistant major depressive disorder (TRMDD).Mental Health - Depression
- Registration Number
- ACTRN12623000618651
- Lead Sponsor
- Reset Mind Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Participant must be over 18 years of age inclusive, up to 65 years old at
the time of signing the informed consent.
Participant is able to read, understand and agree with the procedures of
the study.
Participants must be diagnosed with major depressive disorder and have
moderate to severe depression (17+ on the 17-item Hamilton Depression
Rating scale [HAM-D17]).
Participants have failed to respond to two adequate courses of
antidepressant treatment of different pharmacological classes lasting at least
6 weeks within the current depressive episode and have not been subject to
Electroconvulsive therapy (ECT) within 6 months prior to the study.
Participants can confirm the involvement and willingness of a family
member during the PAP sessions and duration of the study
Male participants are eligible to participate if they agree to the following
during the study intervention period and for at least 3 months after the
last administration of study intervention:
- Refrain from donating sperm PLUS, either:
- Be abstinent from heterosexual intercourse as their preferred and
usual lifestyle (abstinent on a long term and persistent basis) and
agree to remain abstinent OR;
- Must agree to use contraception/barrier method (condom); the
participant should also be advised of the benefit for a female partner
to use a highly effective method of contraception.
b. Female participants:
A female participant is eligible to participate if she is not pregnant or
breastfeeding, and one of the following conditions applies:
- Is a woman of nonchildbearing potential (WONCBP) such as a woman
in postmenopausal state (has experienced no menses for 12
consecutive months without an alternative medical cause); OR
- Has a documented permanent sterilization method such as:
o Documented hysterectomy
o Documented bilateral salpingectomy
o Documented bilateral oophorectomy, OR
Is a woman on childbearing potential (WOCBP) and agrees to use a
contraceptive method that is highly effective (with a failure rate of
<1% per year), with low user dependency.
A WOCBP must have a negative highly sensitive pregnancy test (urine) during
screening and prior to each psylocibin administration.
Consent for study team to contact participant’s HCP team to notify them
of trial participation and for the arrangement of follow-up care in the event
of discontinuation from the trial (including discontinuation due to withdrawal
of consent from trial participation
Participants unable to provide written informed consent.
Participants with history of current or previously diagnosed psychotic
disorder, or bipolar disorder.
Immediate family member with a diagnosed psychotic disorder.
Participants that are pregnant or breastfeeding. Positive pregnancy test
at screening or prior to any psilocybin administration or refusal to have an
on-site B-HCG pregnancy test prior to any psilocybin administration.
Participants who may have sexual contact, without contraceptive
measures, with a person who may become pregnant during or within 90 days
(or 3 months) of cessation of the psilocybin IMP.
Participants with history of serious suicide attempts or with a current
Columbia-Suicide Severity Rating Scale (C-SSRS) positive (YES) for questions
4,5 or 6, or deliberate self-harm within the last year.
Participants with any of Cluster B personality disorder such as:
• Borderline personality disorder
• Histrionic personality disorder
• Antisocial personality disorder
• Narcissistic personality disorder
Participants with eating disorders such as:
• Anorexia Nervosa
• Bulimia Nervosa
• Binge Eating Disorder
• Other Specified Feeding and Eating Disorder
• Pica
• Rumination Disorder
• Avoidant/Restrictive Food Intake Disorder
• Unspecified Feeding or Eating Disorder
• Other:
o Muscle Dysmorphia
o Orthorexia Nervosa
Participants who are receiving any Selective Serotonin recapture Inhibitor
(SSRI) during the last 4 weeks. A washout period of 4 weeks (5 weeks for
fluoxetine) prior to the enrolment is permitted. Patients who have received an
Inhibitor of Mono-amino-oxidase (MAOIs) or patients receiving any other agent
that may precipitate a serotonin syndrome (such as, but not limited to: LTryptophan, Selective Serotonin Reuptake Inhibitors, Tricyclic antidepressants,
Tramadol, Buspirone, Amphetamines and anorectics, Atypical antidepressants,
St John’s wort, or Lithium) in the previous 4 weeks before the study enrollment.
Participants with known history of serotonin syndrome, neuroleptic
malignant syndrome or malignant hyperthermia.
Moderate to severe systolic or diastolic hypertension, or uncontrolled
mild hypertension, a previous hypertensive crisis or a known or suspected
aneurysm or history of intracerebral haemorrhage.
Participants with evidence of mild to severe moderate hepatic
impairment (Child Pughclass A-C)
Participants with evidence of mild to severe renal impairment
(GFR <70mL/min)
Hypersensitivity to any of the study interventions, including any
constituents thereof, or drug or other allergy that, in the opinion of the
Investigator, contraindicates participation in the study.
Clinically significant abnormal ECG at screening/baseline or during the
dosing period that may, in the judgement of the investigator, affect the
conduct of the study.
Participants with known history of prolonged QT interval conditions or
taking other medications that can prolong QT interval (such as, but not
limited to: amiodarone, astemizole, chlorpromazine, cisapride, erythromycin,
papaverine, procainamide, quinidine, sotalol, terfenadine, vandetanib).
Substance use disorder (excluding nicotine or caffeine) current or in the
last year. Alcohol Use Disorder is as defined per DSM-5. Participants who do
not anticipate being able to refrain from smoking or vaping for 12 hours are
excluded.
Participants not suitable for participation, whatever the reason, as
judged by the Inv
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be compared between groups using Hamilton Depression Rating Scale (HDRS).[ 12 months following last psychotherapy session.]
- Secondary Outcome Measures
Name Time Method <br>To evaluate the efficacy of PAP with or without involving family-members for the treatment of Treatment Resistant Major Depressive Disorder using the Montgomery–Åsberg Depression Rating Scale (MADRS)[ 12 months following last psychotherapy session.]