TREATMENT OF DEPRESSION AND OTHER VARIOUS DISORDERS WITH PSILOCYBIN
The disclosure provides methods for treating a subject in need thereof comprising administering to the subject a therapeutically-effective dose of psilocybin. The methods described herein may be used to treat a variety of diseases, disorders, and conditions. For example, the methods may be used to treat depression, neurocognitive disorders, autism spectrum disorder, and/or attention-deficit/hyperactivity disorder.
1 . A method of treating depression in a subject in need thereof, the method comprising administering an effective amount of crystalline psilocybin to the subject, wherein the crystalline psilocybin is characterized by XRPD peaks at 11.5±0.1, 12.0±0.1, 14.5±0.1, 17.5±0.1 and 19.7±0.1° 20, wherein the crystalline psilocybin has a chemical purity of greater than 97% as determined by HPLC analysis, and wherein the subject has bipolar disorder, or a depressive disorder due to a medical condition.
2 . (canceled)
3 . (canceled)
4 . The method of claim 1 , wherein the subject has bipolar disorder.
5 . The method of claim 4 , wherein the subject has bipolar disorder I.
6 . The method of claim 4 , wherein the subject has bipolar disorder II.
7 . (canceled)
8 . The method of claim 1 , wherein at least one sign or symptom of depression selected from depressed mood, diminished interest in activities, weight loss or gain, decrease or increase in appetite, insomnia or hypersomnia, psychomotor agitation or retardation, fatigue or loss of energy, feelings of worthlessness or excessive or inappropriate guilt, diminished ability to concentrate or indecisiveness, or suicidal ideation or behavior is reduced.
9 . (canceled)
10 . (canceled)
11 . The method of claim 8 , wherein the clinical depression rating scale is a Quick Inventory of Depressive Symptomatology (QIDS)-16 scale, a QIDS-16 daily scale, a Hamilton Depression Rating scale, a Beck Depression Inventory scale, a Montgomery-Asberg Depression Rating Scale, a Clinical Global Impression Scale, a Zung Self-Rating Depression Scale, a Raskin Depression Rating Scale, and/or Young Mania Rating Scale.
12 . The method of claim 8 , wherein the sign or symptom of depression is measured using a Spielberger's Trait and Anxiety Inventory, a Generalized Anxiety Disorder 7-Item Scale, a Warwick-Edinburgh Mental Wellbeing Scale, a Flourishing Scale, a Snaith Hamilton Anhedonia Pleasure Scale, a Life Orientation Test, a Meaning in Life Questionnaire, a Brief Resilience Scale, a Dysfunctional Attitudes Scale, a 44-item Big Five Inventory, a Peters 21-item Delusional Inventory, an Examination of Anomalous Self-Experience, a Ruminative Responses Scale, a White Bear Suppression Inventory, a Barrett Impulsivity Scale, a Brief Experiential Avoidance Questionnaire, a Modified Tellegen Absorption Questionnaire, a Scale to Assess Therapeutic Relationship, Credibility/Expectancy Questionnaire, a Connectedness to Nature Scale, a Political Perspective Questionnaire, a Social Connectedness Scale, a Bech-Rafaelsen Mania Rating Scale, a Revised Santa Clara brief compassion scale, a Gratitude Questionnaire, a Short Suggestibility Scale, a Rosenberg Self-Esteem Scale, a Universality Subscale of the Spiritual Transcendence Scale, an Oxford Questionnaire on the Emotional Side-effects of Antidepressants, a Lauks Emotional Intensity Scale, Sexual Dysfunction Questionnaire, a Brief Index of Sexual Functioning for Women, a Sexual Perceptions Questionnaire, a Barnes Akathisia Rating Scale, a Work Productivity and Activity Impairment Questionnaire, a Work and Social Adjustment Scale, a Connectedness Questionnaire, a Standard Assessment of Personality, a Positive and Negative Syndrome Scale, a Mastery Insight Scale, a Self-Reflection and Insight Scale, a Psychological Insight Scale, a Metaphysical Beliefs Questionnaire, a Spiritual Bypassing Scale, an Adverse Childhood Experience Questionnaire, a Therapeutic Music Experience Questionnaire, a Setting Questionnaire, an Absorption in Music Scale, a Psychedelic Predictor Scale, a Surrender Scale, a EuroQOL-5 Dimension-3 Level Scale, a Columbia-Suicide Severity Rating Scale, a Suicidal Ideation Attributes Scale, or any combinations thereof.
13 . The method of claim 8 , wherein the functional MRI measures the amygdala blood oxygen level-dependent (BOLD) response, and wherein the BOLD response is measured at resting state, in response to emotional faces, and/or music as a hedonic stimulus.
14 . (canceled)
15 . The method of claim 8 , wherein at least one sign or symptom of depression is alleviated within 24 hours of administration of the crystalline psilocybin.
16 . The method of claim 8 , wherein at least one symptom of depression is alleviated within 1 week of administration of the crystalline psilocybin.
17 . The method of claim 8 , wherein at least one symptom of depression is alleviated for a period of at least 1 month after administration of the crystalline psilocybin.
18 . The method of claim 8 , wherein the at least one symptom of depression is alleviated for a period of at least 3 months after administration of the crystalline psilocybin.
19 . The method of claim 8 , wherein the at least one symptom of depression is alleviated for a period of at least 12 months after administration of the crystalline psilocybin.
20 - 35 . (canceled)
36 . The method of claim 1 , wherein the crystalline psilocybin has no single impurity of greater than 1%.
37 - 55 . (canceled)
56 . The method claim 1 , wherein the crystalline psilocybin is administered in an oral dosage form.
57 . The method of claim 56 , wherein the oral dosage form is a capsule.
58 . The method of claim 56 , wherein the oral dosage form is a tablet.
59 . (canceled)
60 . The method of claim 1 , wherein the effective amount of crystalline psilocybin is in the range of about 0.1 mg to about 100 mg.
61 . The method of claim 60 , wherein the effective amount of crystalline psilocybin is about 1 mg.
62 . The method of claim 60 , wherein the effective amount of crystalline psilocybin is about 10 mg.
63 . The method of claim 60 , wherein the effective amount of crystalline psilocybin is about 25 mg.
64 - 77 . (canceled)
78 . The method of claim 1 , wherein the crystalline psilocybin is administered by one of the following routes: oral, intravenous, intramuscular, parenteral, topical, inhalation, rectal, transmucosal, intranasal, buccal, vaginal, intrathecal, intraocular, transdermal, in utero, intralymphatic, or by direct tissue or organ injection.
79 . The method of claim 78 , wherein the crystalline psilocybin is administered orally.
80 . The method of claim 1 , wherein the subject participates in at least one psychological support session before administration of the crystalline psilocybin.
81 - 83 . (canceled)
84 . The method of claim 1 , wherein the subject participates in at least one psychological support session after administration of the crystalline psilocybin.
85 - 162 . (canceled)