Major Depressive Disorder
Conditions
Keywords
MDD, Adjunctive, antidepressant, 5HT2a agonist
Brief summary
This is a three-part Phase 2a study. The aim of Part A is to assess the safety and tolerability and preliminary antidepressant efficacy in patients with MDD who are not currently on an antidepressant therapy. The aim of Part B is to assess the antidepressant efficacy, safety and tolerability in patients with MDD who are partial responders while on a current and adequate single SSRI or SNRI treatment. Part C aims to replicate the monotherapy findings of Part A, but with a lower control group dose.
Interventions
DRUGGM-2505
IV
Sponsors
Gilgamesh Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Patients are male or female, of any ethnic origin. 2. Patients are aged between 18 to 65 years, inclusive. 3. Patients meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for recurrent MDD without psychotic features, as assessed with the Mini-International Neuropsychiatric Interview (MINI) at Screening. 4. Current moderate to severe MDD diagnosis confirmed with a MADRS-SIGMA 5. Concomitant depression therapy: 1. (Part A) Patients need to be stable and must not have taken any SSRI or SNRI for at least 6 weeks prior to Screening and must be willing to avoid starting a new pharmacological treatment for MDD until the end of the study procedures and assessments. Discontinuing current treatment is not allowed if done for the purposes of achieving eligibility for this study. 2. (Part B) Patients need to be on stable treatment with any SSRI or SNRI for at least 6 weeks prior to screening and must be willing to remain on the SSRI or SNRI for the duration of the trial 3. Patients receiving any form of psychotherapy or counselling must have been receiving therapy at Screening and must be willing to remain in therapy until the end of the study procedures and assessments. Key
Exclusion criteria
1. Patient has current or past primary DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar, or related disorders. A current diagnosis of PTSD, complex PTSD and borderline personality disorder are exclusionary. Other psychiatric disorders besides MDD should not be the primary disorder. 2. In first degree relatives, a history of schizophrenia, psychosis, bipolar disorder, delusional disorder, paranoid personality disorder or schizoaffective disorder. 3. Current or prior (six weeks before Screening) use of any SSRI/SNRI medication (Part A only). 4. Current or prior (five weeks before Screening) use of any monoamine oxidase inhibitor (\[MAO-I\]; including phenelzine, tranylcypromine, isocarboxazid, iproniazid, selegiline, rasagiline, the reversible MAO-I moclobemide and the antibiotic linezolid).or any tricyclic antidepressant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability (Part A, B, and C) | 99 Days | The primary objective of this study is to evaluate the safety and tolerability of two doses of GM-2505 administered to MDD patients at a 2-week interval between doses. |
| MADRS Score (Part B and C) | 29 Days | The estimated difference between Arm 1 and Arm 2 in the changes from baseline in MADRS-SIGMA total score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MADRS-SIGMA total score (Part A) | Days 14 and 29 | Change in MADRS-SIGMA total score between Baseline and Day 29 and comparison of Day 1 low dose vs moderate dose at Day 14 |
| MADRS-SIGMA total score (Part B and C) | All additional timepoints | MADRS-SIGMA scores (change from baseline) |
| PK of GM-2505 (Part C) | Day 16 | Assess the pharmacokinetics of GM-2505 at very low, moderate, and high doses |
Countries
United Kingdom
Contacts
STUDY_CHAIRGerard Marek, MD
Gilgamesh Pharmaceuticals
Outcome results
None listed