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Current and Upcoming MDD (Monotherapy) Studies

MDD Study 1: Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of an investigational medication given as monotherapy in MDD

MDD Study 2: Phase 2, Multicenter, Randomized, Double-Blind Evaluation of the Efficacy & Safety of an oral investigational medication or Placebo for the Reduction of Symptoms of MDD in Adults

MDD Study 2: Phase 2, Multicenter, Randomized, Double-Blind Evaluation of the Efficacy & Safety of an oral investigational medication or Placebo for the Reduction of Symptoms of MDD in Adults

  • Mechanism: potent, selective activator of Kv7.2/7.3 potassium channels
  • Age: 18 - 75 
  • BMI: ≥ 18, ≤ 35 
  • Depressive Episode Duration: 2-24 months 
  • Cannabis: If + at screening, screening phase may be extended by 4 weeks to allow for negative testing. Must test negative prior to the baseline (2nd) visit. 
  • Therapy: Ongoing allowed if stable for at l

  • Mechanism: potent, selective activator of Kv7.2/7.3 potassium channels
  • Age: 18 - 75 
  • BMI: ≥ 18, ≤ 35 
  • Depressive Episode Duration: 2-24 months 
  • Cannabis: If + at screening, screening phase may be extended by 4 weeks to allow for negative testing. Must test negative prior to the baseline (2nd) visit. 
  • Therapy: Ongoing allowed if stable for at least 12 weeks prior to screening 
  • Exclusionary Diagnoses:  
  • No lifetime history: Bipolar disorders, schizophrenia or other psychotic disorders, borderline or narcissistic personality disorders, dementia, delirium, amnesia, neurodegenerative disease or seizure disorder 
  • Within the last 12 months: No OCD, eating or feeding disorders 
  • Within the last 6 months: No AUD or SUD, excluding nicotine 
  • Within the last month: No PTSD 
  • Additional Exclusion Criteria: No East Asian or Southeast Asian participants (a parent or grandparent from an East Asian or Southeast Asian country) 
  • Study Duration: 12 weeks 
  • Payment: $125 each clinic visit, $62.50 for remote call, up to $987.50 if all visits are completed 

MDD Study 2: Phase 2, Multicenter, Randomized, Double-Blind Evaluation of the Efficacy & Safety of an oral investigational medication or Placebo for the Reduction of Symptoms of MDD in Adults

MDD Study 2: Phase 2, Multicenter, Randomized, Double-Blind Evaluation of the Efficacy & Safety of an oral investigational medication or Placebo for the Reduction of Symptoms of MDD in Adults

MDD Study 2: Phase 2, Multicenter, Randomized, Double-Blind Evaluation of the Efficacy & Safety of an oral investigational medication or Placebo for the Reduction of Symptoms of MDD in Adults

  • Mechanism: third-generation oral NMDA receptor modulator
  • Age: 18-64
  • BMI: < 40 
  • Depressive Episode Duration: 3 weeks – 18 months 
  • Cannabis: Must be willing to discontinue at least 14 days prior to the baseline (2nd) visit 
  • Therapy: Ongoing allowed if stable for at least 8 weeks prior to screening 
  • Exclusionary Diagnoses: Treatment-resistant MDD,

  • Mechanism: third-generation oral NMDA receptor modulator
  • Age: 18-64
  • BMI: < 40 
  • Depressive Episode Duration: 3 weeks – 18 months 
  • Cannabis: Must be willing to discontinue at least 14 days prior to the baseline (2nd) visit 
  • Therapy: Ongoing allowed if stable for at least 8 weeks prior to screening 
  • Exclusionary Diagnoses: Treatment-resistant MDD, MDD with psychotic features, other psychotic disorder history, current bipolar disorder or related diagnosis, OCD, ADHD, antisocial or borderline personality disorders 
  • Additional Exclusion Criteria: All nicotine products must be discontinued at least 2 weeks before baseline (2nd visit). No night shifts during trial.  
  • Study Duration: 14 weeks 
  • Payment: $200 each clinic visit, up to $1600 if all visits are completed 

MDD Study 3 (on temporary hold): Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Oral investigational medication versus Placebo in Participants with MDD

MDD Study 2: Phase 2, Multicenter, Randomized, Double-Blind Evaluation of the Efficacy & Safety of an oral investigational medication or Placebo for the Reduction of Symptoms of MDD in Adults

MDD Study 3 (on temporary hold): Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Oral investigational medication versus Placebo in Participants with MDD

  • Mechanism:  kappa opioid receptor antagonist designed to modulate dopamine and reward processing pathways
  • Age: 18 - 65 
  • BMI: ≤ 35 
  • Depressive Episode Duration: 4 weeks – 12 months 
  • Cannabis: Must be negative by baseline (2nd) visit 
  • Therapy: Ongoing allowed if stable for at least 4 weeks prior to screening 
  • Exclusionary Diagnoses:  
  • No lifetime 

  • Mechanism:  kappa opioid receptor antagonist designed to modulate dopamine and reward processing pathways
  • Age: 18 - 65 
  • BMI: ≤ 35 
  • Depressive Episode Duration: 4 weeks – 12 months 
  • Cannabis: Must be negative by baseline (2nd) visit 
  • Therapy: Ongoing allowed if stable for at least 4 weeks prior to screening 
  • Exclusionary Diagnoses:  
  • No lifetime history bipolar disorders, schizophrenia, schizoaffective disorder, schizophreniform, OCD, PTSD or seizures (unless childhood febrile seizures) 
  • Within the last 3 years: No anorexia, bulimia or BED 
  • Within the last year or currently: No personality disorders  
  • Additional Exclusion Criteria: Useful vision in only 1 eye, corneal transplant in either eye, severe dry eye syndrome, or family history of corneal dystrophy 
  • Study Duration: 12 weeks 
  • Payment: $200 screen ($100 clinic visit, $100 eye exam). Clinic: $75-$100. Up to $1000 if all visits are completed  

MDD Study 3: A Multi-center, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of an investigational medication in the Treatment of Adults with MDD

Postpartum Depression Study: Multicenter, Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of an investigational medication for Injection in the Treatment of Patients with Postpartum Depression

MDD Study 3 (on temporary hold): Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Oral investigational medication versus Placebo in Participants with MDD

  • Mechanism: small molecule which targets Sirtuin 6 (SIRT6). An NAD-dependent enzyme, SIRT6 modulates gene expression, metabolism, and repair associated with MDD, the activation of which is thought to alleviate depression
  • Age: 18 - 65 
  • Sex: Female at birth only 
  • BMI: ≥ 18, ≤ 45 
  • Depressive Episode Duration: 6 weeks – 2 years 
  • Cannabis: Not exclu

  • Mechanism: small molecule which targets Sirtuin 6 (SIRT6). An NAD-dependent enzyme, SIRT6 modulates gene expression, metabolism, and repair associated with MDD, the activation of which is thought to alleviate depression
  • Age: 18 - 65 
  • Sex: Female at birth only 
  • BMI: ≥ 18, ≤ 45 
  • Depressive Episode Duration: 6 weeks – 2 years 
  • Cannabis: Not exclusionary if they do not meet criteria for moderate or severe SUD 
  • Therapy: No CBT, others allowed if stable for at least 3 months prior to screening 
  • Exclusionary Diagnoses:  
  • No lifetime history of MDD with psychotic features, schizophrenia or other psychotic disorders, bipolar disorders, personality disorders, or anaphylaxis to any prior medications. No history of seizures (up to 2 episodes of childhood febrile seizure okay).  
  • No current diagnosis of peripartum depression, panic disorder, OCD, ADHD, PTSD, anorexia, or bulimia 
  • Additional Exclusion Criteria: on antidepressant therapy and in remission just prior to onset of current MDE, major trauma or surgery within 3 months of screening 
  • Study Duration: 11 weeks 
  • Payment: Clinic visits: $125, up to $1,000 if all visits are completed 

Postpartum Depression Study: Multicenter, Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of an investigational medication for Injection in the Treatment of Patients with Postpartum Depression

Postpartum Depression Study: Multicenter, Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of an investigational medication for Injection in the Treatment of Patients with Postpartum Depression

Postpartum Depression Study: Multicenter, Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of an investigational medication for Injection in the Treatment of Patients with Postpartum Depression

  • Mechanism: a unique, prodrug that is converted in vivo to an active drug metabolite, 4-hydroxy-diisopropyltryptamine, or 4-OH-DiPT. Although it possesses pharmacology and intense psychedelic effects similar to those of the active metabolite of psilocybin, the psychoactive state lasts for only about half as long. 
  • Age: 18 - 65 
  • BMI: N/A 
  • Depr

  • Mechanism: a unique, prodrug that is converted in vivo to an active drug metabolite, 4-hydroxy-diisopropyltryptamine, or 4-OH-DiPT. Although it possesses pharmacology and intense psychedelic effects similar to those of the active metabolite of psilocybin, the psychoactive state lasts for only about half as long. 
  • Age: 18 - 65 
  • BMI: N/A 
  • Depressive Episode: Patient is < 15 months postpartum with MDE starting between 2nd trimester through 4 weeks following delivery 
  • Cannabis: If + UDS at screening, must be willing to discontinue and test negative at dosing day 
  • Therapy: Okay if stable for at least 30 days prior to screening 
  • Exclusionary Diagnoses:  
  • No lifetime history of postpartum psychosis, bipolar disorders, schizophrenia, schizoaffective disorder, psychosis, or borderline personality disorder 
  • No 1st degree family history of psychosis or bipolar disorders 
  • No current treatment-resistant depressive episode 
  • No history of seizures aside from childhood febrile seizures 
  • Additional Exclusion Criteria: Must have stopped breastfeeding before screening appointment 
  • Study Duration: 7 weeks 
  • Payment: Clinic visits: $200, up to $1,200 if all visits are completed 

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