Depression, Unipolar, Depressive Disorder
Conditions
Brief summary
This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in patients with partial response in depression.
Detailed description
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.
Interventions
DMT will be administered using a vaporizer device in an ascending fixed-order of 15mg and 60mg.
Sponsors
Universidade Federal do Rio Grande do Norte
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients in current treatment for depression with a partial response.
Exclusion criteria
* heart failure * liver failure * kidney failure * uncontrolled high blood pressure * history of heart rhythm disorders * history of valvular heart disease * history of chronic obstructive pulmonary disease (COPD) * active or in treatment for bronchial asthma * severe obesity * coagulation disorders * clinical evidence or history of increased intracranial * clinical evidence or history of cerebrospinal pressure * history or reports of epilepsy * severe neurological disease * pregnancy * reported or clinically recognized thyroid disorders * diagnosis or family suspicion of genetic monoamine deficiency oxidase * previous adverse response to psychedelic substances * symptoms or family members with a present or past psychotic disorder * dissociative identity disorder * bipolar affective disorder * prodromal symptoms of schizophrenia * problematic use or abuse of alcohol or other psychoactive substances (except tobacco) * acute or subacute risk of suicide * acute flu symptoms * symptoms of airway infection * contact with a confirmed case of COVID-19 (SARS-CoV-2) in the last 7 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in MADRS scores | 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PHQ-9 scores | 7 days | 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. |
| Change in BSI scores. | 1 day | 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. |
| Change in MADRS scores 14 days | 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. |
| Change in MADRS scores 1 month | 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. |
| Change in MADRS scores 3 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma level of C-reactive protein (CRP) | up to 2 hours | Assessed 2 times on each session |
| Plasma level of cortisol | up to 2 hours | Assessed 2 times on each session |
| Plasma level of brain derived neurotrophic factor | up to 2 hours | Assessed 2 times on each session |
| Plasma level of glucose | up to 2 hours | Assessed 2 times on each session |
| Plasma level of total cholesterol | up to 2 hours | Assessed 2 times on each session |
| Plasma level of urea | up to 2 hours | Assessed 2 times on each session |
| Evaluate the subjective effects of DMT | up to 2 hours | 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. |
| Plasma level of aspartate transaminase (AST) | up to 2 hours | Assessed 2 times on each session |
| Plasma level of alanine transaminase (ALT) | up to 2 hours | Assessed 2 times on each session |
| Evaluate the mystical effects of DMT | up to 2 hours | 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. |
| Evaluate the influence of expectations on improvement in depressive symptoms | up to 0.5 hours | 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. |
| Evaluate the influence of personality trait, by BFI (Big Five Inventory) | up to 3 months | 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. |
| Plasma level of creatinine | up to 2 hours | Assessed 2 times on each session |
| Systolic Blood Pressure | up to 2 hours | Assessed 7 times on each session |
| Diastolic Blood Pressure | up to 2 hours | Assessed 7 times on each session |
| Heart rate | up to 2 hours | Assessed 7 times on each session |
| Respiratory rate | up to 2 hours | Assessed 7 times on each session |
| Oxygen saturation | up to 2 hours | Assessed 7 times on each session |
Countries
Brazil
Outcome results
None listed