Diabetes MellitusPhase 1NCT05526430
Study of Harmine in Healthy Subjects
A Phase 1 study testing Harmine Hydrochloride Capsules in people with Diabetes Mellitus, run by James Murrough at 1 site in United States.
Trial summary
The present study is a phase 1 dose escalation study of harmine in healthy volunteers. The primary goal of the trial is to determine the maximum tolerated dose of harmine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Harmine Hydrochloride Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2022to 23 Jun 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18-55 years;
- Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process;
- Body Mass Index (BMI) between 19 and 30;
- Women of childbearing potential and men must be using an acceptable method of contraception to avoid pregnancy throughout the study as judged by the investigator;
- Women must not be breastfeeding;
Who cannot join
- Children under the age of 18 and adults over the age of 55 due to concerns regarding neurodevelopmental and neurocognitive effects, respectively.
- Individuals who are underweight as defined as a BMI <19, or who are obese as defined as >30 according to the Centers for Disease Control (CDC). These criteria are in line with the goals of a phase I dose finding and pharmacokinetic study.
- Presence of a significant medical illness i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry;
- Presence of a significant neurological disease such as Parkinson's disease, primary or secondary seizure disorders, intracranial tumors, severe head trauma; neurodegenerative diseases;
- Presence of neurocognitive or dementing disorders;
- Presence or history of psychiatric disorder as diagnosed by Mini Neuropsychiatric Interview (MINI);
Show all 19Show fewer
- Urine toxicology positive for illicit drugs or dis-allowed concomitant medications as per study protocol;
- Medications with primary central nervous system (CNS) effects are dis-allowed, including psychotropic medications, antidepressants, benzodiazepines, centrally acting hypnotic agents, and centrally acting anti-migraine therapies;
- Medications with primary cardiovascular effects are dis-allowed, including beta-adrenergic antagonists, ACE inhibitors, calcium channel blockers, and diuretics;
- Any OTC medications or herbal remedies (see concomitant medications listed above) that could interfere with the study drug, pose a risk to the subject, or contain high tyramine as outlined in the Low Tyramine Diet attachment and above in the concomitant medication summary;
- Any other medications that, in the opinion of the investigators, would pose a safety risk to the patient or that would interfere with the interpretation of study results; Positive pregnancy test at screen or on the morning of the treatment day in women of childbearing potential;
- Systolic blood pressure outside the range of 100 - 140 mmHg, diastolic blood pressure outside the range of 60 - 90 mmHg, and pulse rate at rest > 100 or < 60 bpm;
- History of positive tests for hepatitis B surface antigen, hepatitis C antibodies;
- History of HIV;
- Significant ECG abnormalities as follows:
- Heart Rate < 60 and >100 bpm
- PR Interval <120 and > 220 ms
- QRS duration < 70 and >120 ms
- QTC Interval (Bazett) > 450 ms
Trial locations and contacts
1 site in 1 country.
United States1 site
Depression and Anxiety Center
New York, New York, 10029
About this study
Official title: A Phase I Dose Escalation Study of Harmine in Healthy Subjects
The present study is a phase 1 dose escalation study of harmine in healthy volunteers. The primary goal of the trial is to determine the maximum tolerated dose of harmine.
Read the detailed description
The present study is a phase 1 dose escalation study of harmine in healthy volunteers. The primary goal of the trial is to determine the maximum tolerated dose of harmine. Harmine will be administered in an open-label, dose escalation design that will use the continual reassessment method to inform the next dose to test in a subject. There will be a total of seven possible doses that include 100 mg, 200 mg, 300 mg, 500 mg, 700 mg, 900 mg and 1200 mg. Each study subject will receive a single oral dose of harmine in this single ascending dose design. On the treatment day, subjects will undergo continuous medical monitoring. All adverse events will be documented and events that qualify as dose limiting toxicities (DLTs) will be used to inform dosing for the subsequent subjects.
- Conditions
- Diabetes Mellitus
- Being tested
- Harmine Hydrochloride Capsules
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmine Hydrochloride CapsulesDrug
capsules taken orally
| Study group | Role | What they receive |
|---|---|---|
| Harmine Dose | Experimental | There will be a total of seven possible doses that include 100 mg, 200 mg, 300 mg, 500 mg, 700 mg, 900 mg and 1200 mg. Each study subject will receive a single oral dose of harmine in this single ascending dose design. Receives: Drug: Harmine Hydrochloride Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicity (DLT)
DLT which is defined if have any one of the following:
Patient Rated Inventory of Side Effects (PRISE): 0-51, higher scores indicate more adverse events observed
Brief Psychiatric Rating Scale (BPRS): 4 - 28, higher scores indicate more symptoms of psychosis
Vitals: blood pressure and heart rate will all be measured - anything outside of the following ranges will be noted:
- Symptomatic hypotension, or > 20% decrease in systolic blood pressure (SBP) from pre-dosing and an absolute SBP < 90; or
- Symptomatic hypertension, or > 20% increase in SBP or diastolic blood pressure (DBP) from predosing and absolute SBP > 170 or DBP > 95;
- New onset tachycardia (heart rate >100 bpm) and >20% increase from pre-dosing; or symptomatic bradycardia (heart rate <60 bpm) and > 20% decrease from pre-dosing.
- Signs and symptoms of cardiac ischemia, defined by acute ischemic changes on ECG with or without concomitant symptoms
Measured: 24 hours
Maximum Tolerated Dose (MTD) of Oral Harmine HCl Based on Dose Limiting Toxicity (DLT)
The MTD was determined to be between 100 and 200mg and is weight-based.
Measured: 24 hours
Secondary outcomes (20)
Visual Analog Scale (VAS) - Nausea
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly
Measured: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Hunger
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly.
Measured: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Feeling High/Intoxicated
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly
Measured: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Drowsiness
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly
Measured: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Anxiety
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly
Measured: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Depressed Mood
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly.
Measured: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Happy Mood
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly
Measured: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Excitement
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly.
Measured: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Feeling of Control
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly.
Measured: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Vividness of Image
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly.
Measured: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale
The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments.
Items are rated on a four-point scale from 0 "much unlike this" to 3 "much like this." It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood
Measured: Baseline, 2, 6, 7, 8, and 24 hours
Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale
The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments.
Items are rated on a four-point scale from 0 "much unlike this" to 3 "much like this." It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood
Measured: Baseline, 2, 6, 7, 8, and 24 hours
Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale
The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments.
Items are rated on a four-point scale from 0 "much unlike this" to 3 "much like this." It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood
Measured: Baseline, 2, 6, 7, 8, and 24 hours
Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale
The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments.
Items are rated on a four-point scale from 0 "much unlike this" to 3 "much like this." It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood
Measured: Baseline, 2, 6, 7, 8, and 24 hours
Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale
The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments.
Items are rated on a four-point scale from 0 "much unlike this" to 3 "much like this." It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood
Measured: Baseline, 2, 6, 7, 8, and 24 hours
Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale
The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments.
Items are rated on a four-point scale from 0 "much unlike this" to 3 "much like this." It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood
Measured: Baseline, 2, 6, 7, 8, and 24 hours
Perceived Stress Scale (PSS)
The PSS is a 10-item self-report scale that measures the perception of stress. Each item is rated on a scale from 0-4. Full scale from 0-40, with higher score indicating more perceived stress
Measured: 24 hours
Patient Rated Inventory of Side Effects (PRISE)
The PRISE is a self-report Adverse Event (AE) Checklist used to qualify side effects by identifying and evaluating the tolerability of each symptom.
Only new onset or worsening symptoms were included. Participants could report more than one AE.
Measured: 24 hours
Brief Psychiatric Rating Scale (BPRS)
The BPRS is a 16-item clinician- administered scale that captures acute behavioral changes throughout treatment. Each item is rated on a scale from 1-7. Full scale from 16-112 with higher score indicating more worse health outcomes.
Measured: Baseline, 2, 6, 7, 8, and 24 hours
Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a clinician-administered suicidal ideation and behavior rating scale used to evaluate suicide risk. Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start13 Sep 2022
- Primary completion23 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This study will employ the continual reassessment method (CRM) to find an MTD of Harmine. It uses a statistical model to estimate the relationship between dose and DLT risk to inform decisions on dosing. It first starts with a selected target DLT rate and a mathematical model for the relationship between dose and toxicity, the prior dose-toxicity curve. After a patient experiences a DLT or not, the dose-toxicity curve is re-fit incorporating the latest outcome. The next dose assigned is that most likely to be associated with the target toxicity level (the MTD). At every step, the next patient is assigned the dose estimated to be nearest to the MTD.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- James Murrough
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, James Murrough, Icahn School of Medicine at Mount Sinai
- Investigators
- James Murrough, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526430
- Sponsor's protocol ID
- GCO 20-1458
- Other IDs
- 1R01DK128242-01A1
- Status last verified
- Jan 2025
- First submitted
- 31 Aug 2022
- Last updated
- 16 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: As of now the study team is not plan on sharing IPD as that would not align with the approved management plan.
Publications
Ables JL, Israel L, Wood O, Govindarajulu U, Fremont RT, Banerjee R, Liu H, Cohen J, Wang P, Kumar K, Lu G, DeVita RJ, Garcia-Ocana A, Murrough JW, Stewart AF. A Phase 1 single ascending dose study of pure oral harmine in healthy volunteers. J Psychopharmacol. 2024 Oct;38(10):911-923. doi: 10.1177/02698811241273772. Epub 2024 Sep 20.
PubMed 39301926
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of Harmine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05526430
- Acronym / sponsor ID
- GCO 20-1458
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- James MurroughUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Posted 16 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is a phase 1 dose escalation study of harmine in healthy volunteers. The primary goal of the trial is to determine the maximum tolerated dose of harmine.
Detailed description
The present study is a phase 1 dose escalation study of harmine in healthy volunteers. The primary goal of the trial is to determine the maximum tolerated dose of harmine. Harmine will be administered in an open-label, dose escalation design that will use the continual reassessment method to inform the next dose to test in a subject. There will be a total of seven possible doses that include 100 mg, 200 mg, 300 mg, 500 mg, 700 mg, 900 mg and 1200 mg. Each study subject will receive a single oral dose of harmine in this single ascending dose design. On the treatment day, subjects will undergo continuous medical monitoring. All adverse events will be documented and events that qualify as dose limiting toxicities (DLTs) will be used to inform dosing for the subsequent subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will employ the continual reassessment method (CRM) to find an MTD of Harmine. It uses a statistical model to estimate the relationship between dose and DLT risk to inform decisions on dosing. It first starts with a selected target DLT rate and a mathematical model for the relationship between dose and toxicity, the prior dose-toxicity curve. After a patient experiences a DLT or not, the dose-toxicity curve is re-fit incorporating the latest outcome. The next dose assigned is that most likely to be associated with the target toxicity level (the MTD). At every step, the next patient is assigned the dose estimated to be nearest to the MTD.
| Arm | Type | Receives |
|---|---|---|
| Harmine Dose | Experimental | Drug: Harmine Hydrochloride CapsulesThere will be a total of seven possible doses that include 100 mg, 200 mg, 300 mg, 500 mg, 700 mg, 900 mg and 1200 mg. Each study subject will receive a single oral dose of harmine in this single ascending dose design. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female aged 18-55 years;
- Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process;
- Body Mass Index (BMI) between 19 and 30;
- Women of childbearing potential and men must be using an acceptable method of contraception to avoid pregnancy throughout the study as judged by the investigator;
- Women must not be breastfeeding;
Key exclusion criteria (19 listed)
- Children under the age of 18 and adults over the age of 55 due to concerns regarding neurodevelopmental and neurocognitive effects, respectively.
- Individuals who are underweight as defined as a BMI <19, or who are obese as defined as >30 according to the Centers for Disease Control (CDC). These criteria are in line with the goals of a phase I dose finding and pharmacokinetic study.
- Presence of a significant medical illness i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry;
- Presence of a significant neurological disease such as Parkinson's disease, primary or secondary seizure disorders, intracranial tumors, severe head trauma; neurodegenerative diseases;
- Presence of neurocognitive or dementing disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harmine Hydrochloride Capsulescapsules taken orally | Drug | Harmine Dose |
Primary outcome
Number of Participants With Dose Limiting Toxicity (DLT)
Time frame: 24 hours
DLT which is defined if have any one of the following: Patient Rated Inventory of Side Effects (PRISE): 0-51, higher scores indicate more adverse events observed Brief Psychiatric Rating Scale (BPRS): 4 - 28, higher scores indicate more symptoms of psychosis Vitals: blood pressure and heart rate will all be measured - anything outside of the following ranges will be noted: * Symptomatic hypotension, or > 20% decrease in systolic blood pressure (SBP) from pre-dosing and an absolute SBP < 90; or * Symptomatic hypertension, or > 20% increase in SBP or diastolic blood pressure (DBP) from predosing and absolute SBP > 170 or DBP > 95; * New onset tachycardia (heart rate >100 bpm) and >20% increase from pre-dosing; or symptomatic bradycardia (heart rate <60 bpm) and > 20% decrease from pre-dosing. * Signs and symptoms of cardiac ischemia, defined by acute ischemic changes on ECG with or without concomitant symptoms
Maximum Tolerated Dose (MTD) of Oral Harmine HCl Based on Dose Limiting Toxicity (DLT)
Time frame: 24 hours
The MTD was determined to be between 100 and 200mg and is weight-based.
20 secondary outcomes
Visual Analog Scale (VAS) - Nausea
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Hunger
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Feeling High/Intoxicated
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Drowsiness
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Anxiety
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Depressed Mood
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Happy Mood
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Excitement
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Feeling of Control
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Visual Analog Scale (VAS) - Vividness of Image
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Perceived Stress Scale (PSS)
Time frame: 24 hours
Patient Rated Inventory of Side Effects (PRISE)
Time frame: 24 hours
Brief Psychiatric Rating Scale (BPRS)
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39301926Ables JL, Israel L, Wood O, Govindarajulu U, Fremont RT, Banerjee R, Liu H, Cohen J, Wang P, Kumar K, Lu G, DeVita RJ, Garcia-Ocana A, Murrough JW, Stewart AF. A Phase 1 single ascending dose study of pure oral harmine in healthy volunteers. J Psychopharmacol. 2024 Oct;38(10):911-923. doi: 10.1177/02698811241273772. Epub 2024 Sep 20.
- Individual participant dataSharing planned: No. As of now the study team is not plan on sharing IPD as that would not align with the approved management plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Murrough, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Harmine Hydrochloride Capsules in people with Diabetes Mellitus, run by James Murrough at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting Toxicity (DLT) (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05526430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.