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Psychedelic Therapy Inclusion and Exclusion Criteria: Difference between revisions
Psychedelic Therapy Inclusion and Exclusion Criteria (view source)
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(Created page with "Certain types of patient are more at risk of certain side effects to psychedelic medicine. Therefore, a judgement needs to be made pre-administration to recommend to the patient where it is safe to take the medicine or not. Below is a list of inclusion criteria (people who would be deemed less likely for adverse effects) and exclusion criteria (those that it should not be recommended to take psychedelics). == Inclusion Criteria == Participants meeting a...") |
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Certain types of patient are more at risk of | '''Certain types of patient are more at risk of adverse side effects to [[Psychedelics|psychedelic]] medicine. Therefore, a judgement needs to be made pre-administration to recommend to the patient where it is safe to take the medicine or not.''' We have created a [[Psychedelic Therapy Risk Analysis Tool]] to aid in this determination. | ||
In the vast majority of cases the benefits of taking psychedelics outweighs the potential risks. However, in general, there are certain psychedelic exclusion criteria which would mean someone should not be immediately recommended therapy, these include: | |||
* People taking '''Kentanserin''' (a rare research chemical) or '''olanzapine''' (an atypical antipsychotic) as they can can [[Trip Terminator|''terminate'' a trip]]. | |||
* There is some evidence to suggest people with history of '''psychosis' ''should not take psychedelics;''''' Quite ironically, Aldous Huxley - the man who co-created the word "''psychedel''<nowiki/>''ic''', had a brother with bipolar disorder and a history of psychosis in his family,- would be screened out of most psychedelic trials and clinics today. | |||
* Presence or history of '''mania, personality''' or '''bipolar disorder.''' | |||
More specifically, taking the most recent clinical trials<ref>'''Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication.''' '''Goodwin, G.M., Croal, M., Feifel, D. ''et al.''''' ''Neuropsychopharmacol.'' (2023). Accessed 15 Jul 2023 via <nowiki>https://www.nature.com/articles/s41386-023-01648-7</nowiki></ref> into account, below is a composite of Best Practice. | |||
== Inclusion Criteria == | == Inclusion Criteria == | ||
Participants meeting all the following inclusion criteria at Screening were considered for admission into the study. | Participants meeting all the following inclusion criteria at Screening were considered for admission into the study. | ||
1. Signed Informed Consent | 1. Signed Informed Consent. | ||
2. 18 years of age or older at Screening. | 2. 18 years of age or older at Screening. | ||
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''Psychiatric Exclusion Criteria:'' | ''Psychiatric Exclusion Criteria:'' | ||
1. Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history, MSI-BPD and a structured clinical interview (MINI version 7.0.2). | 1. Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder<ref name=":0">'''Psychiatric risks for worsened mental health after psychedelic use''': Alessia Marrocu, Hannes Kettner, Brandon Weiss. Centre for Psychedelic Research Imperial College London (2023)</ref>, as assessed by medical history, MSI-BPD and a structured clinical interview (MINI version 7.0.2). | ||
2. Prior electroconvulsive therapy and/or ketamine for current episode. | 2. Prior electroconvulsive therapy and/or ketamine for current episode. | ||
3. Ongoing use of an antidepressant medication, including augmentation or combination therapies, other than a single SSRI at Screening and Baseline. | 3. Ongoing use of an antidepressant medication, including augmentation or combination therapies, other than a single SSRI at Screening and Baseline with the exception of those taking MAOI containing psychedelics including but not exclusively ayahuasca. | ||
4. Current psychological therapies that would not remain stable within 21 days the psychedelic administration session. Psychological therapies cannot be initiated within 21 days of Baseline. | 4. Current psychological therapies that would not remain stable within 21 days the psychedelic administration session. Psychological therapies cannot be initiated within 21 days of Baseline. | ||
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9. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may have interfered with the interpretation of the study results or constitute a health risk for the participant if he/she took part in the study. | 9. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may have interfered with the interpretation of the study results or constitute a health risk for the participant if he/she took part in the study. | ||
== Adverse Effects == | |||
All medicines taken without proper guidance can result in adverse effects. Psychedelics are not immune to this distinction, in general, around about 10% of patients experience adverse effects from taking a psychedelic<ref name=":0" />. If in doubt check potential [[Adverse Psychedelic Effects|adverse effects to psychedelics]] for more information. | |||
== Notable Omissions == | |||
'''SSRIs (Selective Serotonin Reuptake Inhibitors) and [[psychedelics]] do not have a strong enough interaction that could lead to serotonin syndrome, a serious and potentially life-threatening condition.''' However, research has indicated that there is a mild interaction between psychedelics and antidepressants, such as SSRIs, which may reduce the effectiveness of the psychedelics. For more information, read the following article on the interaction between [[SSRI and psychedelics|'''SSRIs''' and psychedelic]]<nowiki/>s. | |||
'''Reference''' | |||