5-METHOXY-N,N-DIMETHYLTRYPTAMINE FOR THE TREATMENT OF POSTPARTUM DEPRESSION

1 . 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating a patient suffering from postpartum depression (PPD) wherein the 5-MeO-DMT is administered via the intravenous, intramuscular or subcutaneous route.

2 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claim 1 , wherein the patient has a Montgomery-Åsberg Depression Rating Scale (MADRS) score of 20 or more or a 17-item Hamilton Depression Rating Scale (HAM-D) score of 16 or more.

3 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claim 2 , wherein the patient has a MADRS score of 28 or more or a HAM-D score of 22 or more.

4 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claim 2 , wherein the patient has a MADRS score of 35 or more or by a HAM-D score of 27 or more.

5 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 4 , wherein the patient is diagnosed with a treatment-resistant form of postpartum depression.

6 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 5 , wherein the patient suffers in addition from suicidal ideation.

7 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 6 , wherein the patient suffers in addition from slightly compromised, compromised or severely compromised maternal functioning.

8 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claim 7 , wherein the patient has a Barkin Index of Maternal Functioning (BIMF) score of 95 or below such as 80 or below, in particular 65 or below.

9 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 8 , wherein the 5-MeO-DMT or salt thereof is administered at a dose or in a dosage regimen that causes the patient to experience a peak psychedelic experience.

10 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 9 , wherein a dosage of about 1 mg to about 10 mg 5-MeO-DMT is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT.

11 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 9 , wherein a dosage of about 2 mg; or of about 5 mg; or of about 8 mg is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT.

12 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 9 , wherein a dosage of about 1 mg; or of about 2 mg; or of about 3 mg is administered, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT.

13 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 10 , wherein the 5-MeO-DMT or salt thereof is administered in a first dosage amount for a first administration; and the 5-MeO-DMT or salt thereof is administered in zero to six subsequent administrations; wherein each subsequent administration uses a dosage amount higher than the previous administration unless the patient experiences a peak psychedelic experience.

14 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 10 or 13 , wherein the 5-MeO-DMT is administered in a dosage from about 1 mg to about 3 mg for a first administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 4 mg to about 6 mg for a second administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 7 mg to about 9 mg for a third administration, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT.

15 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claim 14 , wherein the first dosage of 5-MeO-DMT is about 2 mg, the second dosage of 5-MeO-DMT is about 5 mg, and the third dosage of 5-MeO-DMT is about 8 mg; or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT.

16 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 10 or 13 , wherein the 5-MeO-DMT is administered in a dosage from about 0.5 mg to about 1.5 mg for a first administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 1.5 mg to about 2.5 mg for a second administration, and then increased, unless the patient has already experienced a peak psychedelic experience, to a dosage from about 2.5 mg to about 3.5 mg for a third administration, or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT.

17 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claim 16 , wherein the first dosage of 5-MeO-DMT is about 1 mg, the second dosage of 5-MeO-DMT is about 2 mg, and the third dosage of 5-MeO-DMT is about 3 mg; or wherein equimolar amounts of the pharmaceutically acceptable salt are administered instead of 5-MeO-DMT.

18 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 13 to 17 , wherein the interval between two administrations is not less than 1 hour and not more than 24 hours, such as about 1 to 4 hours, preferably about 1 to 2 hours.

19 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 9 to 18 , wherein the occurrence of a peak psychedelic experience is identified through achievement of at least 60% of the maximum possible score in each of the four subscales (mystical, positive mood, transcendence of time and space, and ineffability) of the 30-item revised Mystical Experience Questionnaire (MEQ30) or is identified through achievement of at least 60% of the maximum possible score of the Oceanic Boundlessness (OBN) dimension of the Altered States of Consciousness (ASC) questionnaire or is identified through achievement of a Peak Experience Scale (PES) Total Score of at least 75.

20 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claim 19 , wherein the occurrence of a peak psychedelic experience is identified through achievement of a Peak Experience Scale (PES) Total Score of at least 75.

21 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 20 , wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via intravenous injection.

22 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 21 , wherein a clinical response, as reflected by a reduction in the Clinical Global Impression—Severity (CGI-S) score, occurs not later than about 2 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

23 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 22 , wherein a clinical response, as reflected by a reduction in the Clinical Global Impression—Severity (CGI-S) score, occurs on day 1, for instance, about 24 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

24 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 23 , wherein a clinical response, as reflected by a reduction in the Clinical Global Impression—Severity (CGI-S) score, persists until at least 6 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

25 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 24 , wherein a clinical response, as reflected by a reduction in the Clinical Global Impression—Severity (CGI-S) score, persists until at least 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

26 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 25 , wherein a clinical response, as reflected by a reduction in the Clinical Global Impression—Severity (CGI-S) score, persists until at least 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

27 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 27 , wherein a clinical response, as assessed by at least 50% improvement of the MADRS or HAM-D score, compared to the respective score prior to treatment, occurs not later than about 2 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

28 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 27 , wherein a clinical response, as assessed by at least 75% improvement of the MADRS or HAM-D score, compared to the respective score prior to treatment, occurs not later than about 2 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

29 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 24 , wherein a remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10, or a HAM-D score equal to or less than 7, occurs not later than about 2 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

30 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 29 , wherein a remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10, or a HAM-D score equal to or less than 7, occurs on day 1, for instance, about 24 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

31 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 30 , wherein the clinical response, as assessed by at least 50% improvement of the MADRS or HAM-D score, compared to the respective score prior to treatment, persists until at least 6 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

32 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 31 , wherein there is a clinical response, as assessed by at least 75% improvement of the MADRS or HAM-D score, compared to the respective score prior to treatment, on day 7 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

33 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 32 , wherein the patient is in remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10, or a HAM-D score equal to or less than 7, on day 7 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

34 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 33 , wherein the clinical response, as assessed by at least 50% improvement of the MADRS or HAM-D score, compared to the respective score prior to treatment, persists until at least 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

35 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 34 , wherein there is a clinical response, as assessed by at least 75% improvement of the MADRS or HAM-D score, compared to the respective score prior to treatment, on day 14 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

36 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 35 , wherein the patient is in remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10, or a HAM-D score equal to or less than 7, on day 14 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

37 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 36 , wherein the clinical response, as assessed by at least 50% improvement of the MADRS or HAM-D score, compared to the respective score prior to treatment, persists until at least 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

38 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 37 , wherein there is a clinical response, as assessed by at least 75% improvement of the MADRS or HAM-D score, compared to the respective score prior to treatment, on day 28 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

39 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 38 , wherein the patient is in remission of depressive symptoms, as assessed by a MADRS score equal to or less than 10, or a HAM-D score equal to or less than 7, on day 28 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

40 . 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in any of claims 1 to 39 , wherein the patient is a breastfeeding mother who is advised to discontinue breastfeeding until 48 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

41 . 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in any of claims 1 to 39 , wherein the patient is a breastfeeding mother who is advised to discontinue breastfeeding until 24 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

42 . 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in any of claims 1 to 39 , wherein the patient is a breastfeeding mother who is advised to discontinue breastfeeding until 6 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

43 . 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in any of claims 1 to 39 , wherein the patient is a breastfeeding mother who is advised to discontinue breastfeeding until 3 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

44 . 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in any of claims 1 to 39 , wherein the patient is a breastfeeding mother who is advised to discontinue breastfeeding until 2 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

45 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claims 1 to 44 , wherein the treatment improves maternal functioning.

46 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claim 45 , wherein the improvement relates to one or more, in particular two or more functional domains according to the Barkin Index of Maternal Functioning (BIMF) selected from self-care, infant care, mother-child interaction, psychological wellbeing of the mother, social support, management, and adjustment.

47 . 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as in claim 45 or 46 , wherein the BIMF score is improved by 10% or more, preferably by 20% or more.