Ignite Creation Date:
2024-05-06 @ 9:09 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02914769
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2016-09-21
Brief Title:
Antidepressant Effects of Ayahuasca a Randomized Placebo Controlled Trial in Treatment Resistant Depression
Sponsor:
Universidade Federal do Rio Grande do Norte
Organization:
Universidade Federal do Rio Grande do Norte
Study Overview
Official Title:
Antidepressant Effects of Ayahuasca a Randomized Placebo Controlled Trial in Treatment Resistant Depression
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the present trial is to test the efficacy of Ayahuasca in treatment-resistant depression Ayahuasca is a decoction of two plants long used by Amazonian Amerindians Traditionally it is prepared by decoction of a bush Psychotria viridis with a liana Banisteriopsis caapi P viridis is a rich source of NN-dimethyltryptamine DMT a serotonergic agonist and B caapi contains potent monoamine oxidase-A inhibitors MAOi-A such as harmine harmaline The study is designed as a randomized placebo controlled trial with two parallel arms and it will also evaluate changes of different biomarkers of depression including anatomical and functional Magnetic Resonance Imaging MRI serum levels of BDNF TNF-a cortisol IL-6 and IL-10 polysomnography neuropsychological psychiatric scales and questionnaires
Detailed Description:
1 Background
The therapeutic effectiveness of currently available antidepressant is low Less than 50 of the patients achieve remission after single treatment and about 30 after four different treatments Besides low response rates pharmacological treatment are associated with several side effects and response onset is usually long 2-3 weeks Thus great effort has been made to the development of alternative antidepressants For instance ketamine a N-methyl-D-aspartate NMDA receptor antagonist has rapid and potent antidepressant effects in treatment of major depressive and bipolar disorders
This proposal aims at testing the antidepressant effects of Ayahuasca traditionally prepared by decoction of two plants Psychotria viridis and Banisteriopsis caapi long used by Amazonian Amerindians P viridis is a rich source of the serotonergic agonist NN-dimethyltryptamine DMT whereas B caapi contains potent monoamine oxidase-A inhibitors MAOi-A such as harmine harmaline and tetrahydroharmine a serotonin reuptake inhibitor
Common effects of Ayahuasca include sedation gastrointestinal distress changes of spatiotemporal scaling dissociation sense of well-being insights feelings of apprehension increased interoceptive attention and sensory pseudo-hallucinations Effects begin at 30-40 min after oral intake and last up to 4 hours Previous studies suggest the absence of psychological neuropsychological or psychiatric harm caused by prolonged Ayahuasca consumption and it is not addictive on the contrary it also shows promise in treating addiction
Recently two preliminary open label studies have tested tolerability safety and the antidepressant effect of Ayahuasca in treatment-resistant depression In the first study six patients were recruited in the second 17 patients The results show significant decrease in depression severity HAM-D MADRS scales already at 2 hours after intake which lasted for 21 days Although the results are promising they must be considered with caution specially due to the lack of control of the placebo effect which is generally high in clinical trials
Thus the present study is a randomized placebo-controlled trial in 50 patients with treatment resistant depression Besides the Antidepressant effects of Ayahuasca this study will also evaluate different biomarkers of depression including anatomical and functional Magnetic Resonance Imaging MRI serum levels of BDNF TNF-a cortisol IL-6 and IL-10 polysomnography neuropsychological and psychiatric scales and questionnaires
2 Methods
All 50 patients will undergo routine evaluation including complete blood testing for individual glycemic profile serum cholesterol and triglyceride plasma sodium and potassium urea and creatinine
Patients will undergo a wash-out period between 7 and 14 days prior to the experimental session depending on the lifetime of the antidepressant in use Experiments will take place at the Hospital Universitário Onofre Lopes a tertiary university hospital affiliated to the Universidade Federal do Rio Grande do Norte UFRN Brazil
In the treatment session 25 patients will drink Ayahuasca 25 will drink an inert placebo Psychiatric scales HAM-D MADRS BPRS CADSS and YMRS will be completed during treatment session day one before -D1 one day after D1 two days D2 seven days D7 fourteen days D14 one month M1 and up to six months M6 following the treatment session The following exams will also be conducted at D-1 and D1 neuropsychological tests watch test trail test and N-back structural and functional MRI polysomnography and blood testing BDNF TNF-a cortisol oxytocin IL-6 and IL-10
The therapeutic effectiveness of currently available antidepressant is low Less than 50 of the patients achieve remission after single treatment and about 30 after four different treatments Besides low response rates pharmacological treatment are associated with several side effects and response onset is usually long 2-3 weeks Thus great effort has been made to the development of alternative antidepressants For instance ketamine a N-methyl-D-aspartate NMDA receptor antagonist has rapid and potent antidepressant effects in treatment of major depressive and bipolar disorders
This proposal aims at testing the antidepressant effects of Ayahuasca traditionally prepared by decoction of two plants Psychotria viridis and Banisteriopsis caapi long used by Amazonian Amerindians P viridis is a rich source of the serotonergic agonist NN-dimethyltryptamine DMT whereas B caapi contains potent monoamine oxidase-A inhibitors MAOi-A such as harmine harmaline and tetrahydroharmine a serotonin reuptake inhibitor
Common effects of Ayahuasca include sedation gastrointestinal distress changes of spatiotemporal scaling dissociation sense of well-being insights feelings of apprehension increased interoceptive attention and sensory pseudo-hallucinations Effects begin at 30-40 min after oral intake and last up to 4 hours Previous studies suggest the absence of psychological neuropsychological or psychiatric harm caused by prolonged Ayahuasca consumption and it is not addictive on the contrary it also shows promise in treating addiction
Recently two preliminary open label studies have tested tolerability safety and the antidepressant effect of Ayahuasca in treatment-resistant depression In the first study six patients were recruited in the second 17 patients The results show significant decrease in depression severity HAM-D MADRS scales already at 2 hours after intake which lasted for 21 days Although the results are promising they must be considered with caution specially due to the lack of control of the placebo effect which is generally high in clinical trials
Thus the present study is a randomized placebo-controlled trial in 50 patients with treatment resistant depression Besides the Antidepressant effects of Ayahuasca this study will also evaluate different biomarkers of depression including anatomical and functional Magnetic Resonance Imaging MRI serum levels of BDNF TNF-a cortisol IL-6 and IL-10 polysomnography neuropsychological and psychiatric scales and questionnaires
2 Methods
All 50 patients will undergo routine evaluation including complete blood testing for individual glycemic profile serum cholesterol and triglyceride plasma sodium and potassium urea and creatinine
Patients will undergo a wash-out period between 7 and 14 days prior to the experimental session depending on the lifetime of the antidepressant in use Experiments will take place at the Hospital Universitário Onofre Lopes a tertiary university hospital affiliated to the Universidade Federal do Rio Grande do Norte UFRN Brazil
In the treatment session 25 patients will drink Ayahuasca 25 will drink an inert placebo Psychiatric scales HAM-D MADRS BPRS CADSS and YMRS will be completed during treatment session day one before -D1 one day after D1 two days D2 seven days D7 fourteen days D14 one month M1 and up to six months M6 following the treatment session The following exams will also be conducted at D-1 and D1 neuropsychological tests watch test trail test and N-back structural and functional MRI polysomnography and blood testing BDNF TNF-a cortisol oxytocin IL-6 and IL-10
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None