Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.
This is a phase II open-label, single-ascending, fixed-order study to assess the feasibility and efficacy of inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N,N-Dimethyltryptamine | Experimental | Administration of up to 2 inhaled doses of DMT within a single day (15 mg, followed by 60 mg) with a 1-hour dose interval. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N,N-Dimethyltryptamine | Drug | DMT will be administered using a vaporizer device in an ascending fixed-order of 15mg and 60mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in MADRS scores | Change in MADRS scores from baseline to 7 days after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PHQ-9 scores | Change in PHQ-9 scores from baseline to 7 days after the dosing session. The Patient Health Questionnaire-9 (PHQ-9) is a questionnaire self-reported assessing the severity of the depression. The scale was in french and has 9 items, with an overall score ranging from 0 to 27 points. Higher score indicates more severe depression. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Assessed 7 times on each session | up to 2 hours |
| Diastolic Blood Pressure | Assessed 7 times on each session | up to 2 hours |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Draulio Araujo, Ph.D | Universidade Federal do Rio Grande do Norte | Principal Investigator |
| Marcelo Falchi, M.D. | Universidade Federal do Rio Grande do Norte | Study Director |
| Fernanda Palhano-Fontes, Ph.D | Universidade Federal do Rio Grande do Norte | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário Onofre Lopes | Natal | Rio Grande do Norte | 59012300 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40337754 | Derived | Falchi-Carvalho M, Barros H, Bolcont R, Laborde S, Wiessner I, Ruschi B Silva S, Montanini D, Barbosa DC, Teixeira E, Florence-Vilela R, Almeida R, de Macedo RKA, Arichelle F, Pantrigo EJ, Costa-Macedo JV, Arcoverde E, Galvao-Coelho N, Araujo DB, Palhano-Fontes F. The Antidepressant Effects of Vaporized N,N-Dimethyltryptamine: An Open-Label Pilot Trial in Treatment-Resistant Depression. Psychedelic Med (New Rochelle). 2025 Feb 27;3(1):48-52. doi: 10.1089/psymed.2024.0002. eCollection 2025 Mar. | |
| 40258990 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D004130 | N,N-Dimethyltryptamine |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change in BSI scores. | Change in BSI scores from baseline to 1 day after the dosing session. The Beck rating scale for suicidal ideation (BSI) is a 21-item self-report questionnaire. Each item is rated on a scale from 0 to 2, resulting in a total score ranging from 0 to 38. | 1 day |
| Change in MADRS scores 14 days | Change in MADRS scores from baseline to 14 day after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression. | 14 days |
| Change in MADRS scores 1 month | Change in MADRS scores from baseline to one month after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression. | 1 month |
| Change in MADRS scores 3 months | Change in MADRS scores from baseline to three months after the dosing session. The Montgomery and Asberg Depression Rating Scale (MADRS) is in portuguese and has 10 items, with an overall score ranging from 0 to 60 points. Higher score indicates more severe depression. | 3 months |
| Heart rate | Assessed 7 times on each session | up to 2 hours |
| Respiratory rate | Assessed 7 times on each session | up to 2 hours |
| Oxygen saturation | Assessed 7 times on each session | up to 2 hours |
| Plasma level of C-reactive protein (CRP) | Assessed 2 times on each session | up to 2 hours |
| Plasma level of cortisol | Assessed 2 times on each session | up to 2 hours |
| Plasma level of brain derived neurotrophic factor | Assessed 2 times on each session | up to 2 hours |
| Plasma level of glucose | Assessed 2 times on each session | up to 2 hours |
| Plasma level of total cholesterol | Assessed 2 times on each session | up to 2 hours |
| Plasma level of urea | Assessed 2 times on each session | up to 2 hours |
| Plasma level of creatinine | Assessed 2 times on each session | up to 2 hours |
| Plasma level of aspartate transaminase (AST) | Assessed 2 times on each session | up to 2 hours |
| Plasma level of alanine transaminase (ALT) | Assessed 2 times on each session | up to 2 hours |
| Evaluate the subjective effects of DMT | Assessment of the acute subjective effects of DMT, by 5D-ASC (5 Dimensions - Altered States of consciousness). Scores range from 0 to 94, where higher scores indicate more intense psychedelic subjective effects. | up to 2 hours |
| Evaluate the mystical effects of DMT | Assessment of the acute subjective effects of DMT, by MEQ (Questionnaire of Mystical Experiences). Scores range from 0 to 150, where higher scores indicate more intense psychedelic subjective effects. | up to 2 hours |
| Evaluate the influence of expectations on improvement in depressive symptoms | Assessment of the influence of patient's expectations on improvement in depressive symptoms as measured by a 5 point likert scale range from: nothing to extreme. | up to 0.5 hours |
| Evaluate the influence of personality trait, by BFI (Big Five Inventory) | Assessment of the influence of personality trait assessed by the 44-item Big Five Inventory that measures an individual on the Big Five Factors (dimensions) of personality on depressive symptoms. The 5 dimensions are: Extraversion vs. introversion; Agreeableness vs. antagonism; Conscientiousness vs. lack of direction; Neuroticism vs. emotional stability; Openness vs. closedness to experience. | up to 3 months |
| Derived |
| Falchi-Carvalho M, Palhano-Fontes F, Wiessner I, Barros H, Bolcont R, Laborde S, Ruschi B Silva S, Montanini D, C Barbosa D, Teixeira E, Florence-Vilela R, Almeida R, K A de Macedo R, Arichelle F, J Pantrigo E, V Costa-Macedo J, da Cruz Nunes JA, de Araujo Costa Neto LA, Nunes Ferreira LF, Dantas Correa L, da Costa Bezerra RB, Arcoverde E, Galvao-Coelho N, B Araujo D. Rapid and sustained antidepressant effects of vaporized N,N-dimethyltryptamine: a phase 2a clinical trial in treatment-resistant depression. Neuropsychopharmacology. 2025 May;50(6):895-903. doi: 10.1038/s41386-025-02091-6. Epub 2025 Apr 22. |
| D009930 |
| Organic Chemicals |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |