depression Major depressive disorder
Conditions
Interventions
GM-2505 or placebo
Sponsors
Gilgamesh Pharmaceuticals
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Healthy female or male subjects, 18 to 55 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical, surgical a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities to be not clinically significant. 2. Subject has a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive (BMI=weight/height2) at screening. 3. Self-report of at least one prior hallucinogen drug experience that included a meaningful altered state of consciousness (a state in which the subject experienced phenomena that altered his psychological functioning, such as loss of ego boundaries, impaired control of actions and cognition, disembodiment, changed meaning of perception, visual alterations, and audio-visual synesthesia) in the past 5 years. Hallucinogenic substances can include psilocybin, LSD, DMT, ayahuasca, mescaline, ibogaine, 2C-drugs (such as 2CB, 2CI and 2CE) and/or ketamine. 4. Subjects must be willing to adhere to the prohibitions and restrictions specified in the protocol, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations. 5. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and procedures required for the study and are willing to participate in the study. Agree to refrain from using any psychoactive drugs from 30 days before first dosing and until the last follow-up visit and to refrain from using alcoholic beverages within 48 hours prior to admission of each treatment period.
Exclusion criteria
Exclusion criteria: 1. Clinically significant current or previous liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, metabolic or inflammatory illness, or any other illness that would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements according to the investigator. 3. Subject has a history of or current hypertension (resting systolic blood pressure > 130 mmHg or diastolic blood pressure >90 mmHg) at screening. 5. Resting heart rate (HR) greater than 100 or less than 45 beats per minute (bpm) at screening. 7. Clinically significant personal or familial history of epilepsy, seizures, convulsions, or other seizure disorder (excluding febrile seizures as a child), previous head trauma or other risk factor for seizure. 8. Clinically significant current or previous psychiatric disorder according to DSM 5. Specifically, current or previous psychotic disorders and bipolar disorder will be excluded. 9. Family history of a psychotic disorder (whether in the context of bipolar disorder, schizophrenia or schizoaffective disorder) in first-degree and second-degree relatives. 10. Clinically significant current or previous suicidality based on the C-SSRS and psychiatric history indicating current suicidal ideation or a history of active suicidal ideation or suicide attempts 11. Subject has a current or history of drug or alcohol use disorder according to the to DSM-IV and/or DSM 5 within the past 12 months. 12. Use of psychoactive substances (including ketamine, esketamine, MDMA, cannabinoids, and nitrous oxide), during the 6 weeks prior to screening. Single/occasional use may be allowed at the discretion of investigator. 13. Ingestion of psychedelics (including psilocybin, DMT/ayahuasca, LSD, another serotonergic psychedelic) during 4 weeks prior to screening. 14. Persistent psychological effects following the previous use of psilocybin, LSD, DMT, ayahuasca, mescaline, ibogaine, 2C-drugs (such as 2CB, 2CI and 2CE) and/or ketamine. Such effects might include but are not limited to anxiety, depressed mood, paranoid ideation and/or hallucinations (including hallucinogen persisting perception disorder - HPPD) or recurrent flashbacks related to use. 15. Subject has a positive test result(s) for alcohol and/or drugs of abuse (including opiates (including methadone), cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, and benzodiazepines) at screening or admission to the clinical unit. 16. Female subjects with a positive urine pregnancy test or who are lactating at screening or admission to the clinical unit, or women of childbearing potential (WOCBP) who are unwilling to use an effective form of contraception (as defined under lifestyle regulations) for the duration of the study and for 180 days after the last dose. 17. Sexually active male subjects who are unwilling to use an effective form of contraception (as defined under lifestyle regulations) for the duration of the study and for 90 days after the last dose. 18. Use of more than 5 cigarettes (or other tobacco or nicotine products with equivalent nicotine dose) daily within the previous month before the first dose administration, and/or unable or unwilling to not smoke durin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, hematology, serum chemistry, urinalysis, vital signs, 12-lead ECG, occurrence of psychotic symptoms (BPRS), occurrence of suicidal thoughts and ideations (C-SSRS), occurrence of central serotonergic toxicity (Hunter*s Serotonin Toxicity Criteria), and safety-EEG (continuous recording) | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma and urine PK parameters for GM-2505 Urine PK parameters NeuroCart assessments Clinical Rating Scales Other PD parameters | — |
Countries
Netherlands
Outcome results
None listed