Antidepressant effects of psilocybin in pharmaco-resistant depressio
- Conditions
- The study will include 60 patients with pharmaco-resistant depression (30 male, 30 female, aged 18–65). The basic inclusion criterion is the diagnosis of pharmaco-resistant moderate to severe depressive episode (F32.1–2, F33.1–2) without psychotic symptoms as per ICD-10 criteria with a MADRS score over 20 and excluding patinets with MADRS suicidality score (item 10) more than 4.Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2018-004480-31-CZ
- Lead Sponsor
- árodní ústav duševního zdraví
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
1) Men and women aged 18-65
2) Diagnosis of moderate to severe depressive disorder without psychotic symptoms - ICD-10 criteria F32.1-2 or F33.1-2 and at the same time MADRS score > 20
3) The duration of the current depressive epizode is at least 3 months and maximum 2 years
4) Treatement-resistant depression defined as:
a) Failure of at least 2 and at most 4 adequate treatments (6 weeks of full therapeutic dose of antidepressant, adequate non-pharmacological treatemment - eg psychotherapy, neurostimulation treatment, phototherapy, etc.) within the current depressive episode, using at least 2 types of antidepressants with different pharmacological mechanisms of action (augmentation is taken as a second treatment) or
b) Intolerance of 2 different treatments and 1 adequate treatment or
c) Intolerance of 3 different antidepressant treatments.
5) Ability to understand the study protocol and to be able to complete all study visits and examinations as defined per protocol.
5) Participants in a clinical trial of childbearing potential must agree to the use of prescribed contraceptive methods for the duration of the study:
a) Women - Proper use of a highly reliable method of contraception, ie combined hormonal contraceptives (oral, vaginal or transdermal dosage form), gestagen hormonal contraceptives associated with ovulation inhibition (oral or injectable dosage form), non-hormonal intrauterine device or intrauterine device releasing hormones, ev. the presence of bilateral tubal occlusion, a partner's vasectomy, or adherence to sexual abstinence.
b) Men - Adherence to sexual abstinence or the use of an adequate contraceptive method (ie condom) in case of sexual intercourse.
Periodic abstinence is not considered an acceptable method. The clinician, together with the volunteer, chooses the most appropriate method of contraception. The chosen method of contraception will be documented in the screening visit.
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) Serious psychiatric comorbidity (axis I MINI, ICD-10 F0.X - F99.X, the intensity of the disorder will be clinically assessed by the study clinician)
2) The current depressive phase is severe with psychotic symptoms (ICD-10: F32.3, F33.3)
3) MADRS suicidality score (item 10)> 4
4) Suicideal attempt within last 6 months
5) Duration of the current depressive episode longer than 2 years
6) Current drug or alcohol dependence (ICD-10: F17.x) with the exception of tobacco and with the exception of abstinence lasting more than 2 years
7) Claustrophobia, inability to undergo MR examination
8) Pregnancy or breast-feeding or plan to become pregnant within the next 3 months
9) Intracranial hypertension, pulmonary hypertension, uncorrected arterial hypertension (BP> 150/100 mmHg)
10) Condition after stroke, myocardial infarction in the last 6 months
11) Heart failure
12) Untreated or decompensated hyperthyroidism
13) Glaucoma
14) Severe respiratory failure or acute respiratory depression
15) History of seizures
16) Other serious somatic disease or any other circumstance in which a significant increase in blood pressure would pose a serious threat to health (to be assessed by the study clinician)
17) Pacemaker
18) Metal implants made of MR incompatible materials
19) Regular use of medication that could interact with psilocybin (to be assessed by the investigator)
20) Current use of monoamine oxidase inhibitors (MAOIs). Patients can be enrolled if the IMAO treatment will be completely discontinued during tapering at least 14 days prior V0
21) Previous experience with psilocybin, hallucinogenic mushrooms or ketamine is possible in a maximum of 10% of patients. This experience must not be during the last 12 months or during the current depressive episode.
22) Recent use of antidepressants, antipsychotcis or other drugs with a direct antagonistic effect on 5-HT2A receptors (eg trazodone, mirtazapine, mianserin, risperidone, quetiapine, ketanserine) or discontinuation of their use for less than 7 days before dosing with study medication. Patients can be enrolled, but these drugs must be completeley tapered at least 7 days prior V0.
23) Electroconvulsive therapy in the previous 3 months
24) Daily use of benzodiazepine anxiolytics higher than the equivalent of 10 mg diazepam
25) Allergy to any of the components of study drugs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method