A randomized, double-blind, placebo-controlled, Phase 2b trial with an open-label extension to determine the safety and efficacy of GH001 in patients with treatment-resistant depression.

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

Patients are eligible for the trial if all the following criteria are met,
unless they fulfil >=1 of the exclusion criteria:
1. Is informed about the trial, has given informed consent in writing, and is
willing and able to comply with all requirements and rules of the trial.
2. Is in the age range between 18 and 64 years (inclusive) at the time of
informed consent.
3. Meets the trial criteria for TRD as assessed by a study psychiatrist:
a. Meets the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
criteria for single-episode MDD or recurrent MDD, without psychotic features
confirmed by the Mini-International Neuropsychiatric Interview (MINI) 7.0.2
with current episode duration of <=2 years.
b. The current MDE must be deemed *valid* based upon the Massachusetts General
Hospital State versus trait Assessability Face and Ecological validity Rule of
3Ps (MGH-SAFER) criteria interview.

For full details please refer to the Protocol.

Exclusion Criteria

Patients who meet any of the following criteria prior to the first dose of
study drug are not eligible for randomization:
1. Has, based on history, psychiatric assessment, and evaluation of the MINI
version 7.0.2 during the screening period, a first MDD episode after age 60, a
current or prior diagnosis of a psychotic disorder, MDD, or other mood disorder
with psychotic features, bipolar disorder, obsessive compulsive disorder,
posttraumatic stress disorder, autism spectrum disorder, borderline personality
disorder, schizophrenia, delusional disorder, paranoid personality disorder,
schizoaffective disorder, clinically significant intellectual disability,
antisocial personality disorder, schizotypal personality disorder, or any other
psychiatric comorbidity that renders the patient unsuitable for the trial
according to a study psychiatrist.
2. Has significant suicide risk as defined by (a) suicidal ideation as endorsed
on items 4 or 5 on the C-SSRS within the past year, during the screening
period, or at Baseline; or (b) suicidal behaviors within the past year; or (c)
clinical assessment of significant suicidal risk during clinical interview; or
(d) non-suicidal self-injury within the past year.
3. Has 1 or more first degree relatives with a current or prior diagnosis of
bipolar disorder, psychotic disorder, or other mood disorder (including MDD)
with psychotic features.
4. Undergoing systematic psychotherapy (including cognitive behavioral therapy
[CBT]) that is planned to be modified or planning to initiate psychotherapy
during the trial. CBT must have been ongoing for the last 3 months prior to
Baseline.
5. Has any current or past clinically significant condition (e.g., severe
infection, severe pulmonary disease, uncontrolled hypertension, uncontrolled
diabetes, severe cardiovascular disease, valvulopathy, pulmonary hypertension,
myocardial infarction, angina, or clinically significant arrythmia within the
past year, severe hepatic or severe renal failure, brain disorder including
seizure, stroke, dementia, aneurysm, history of intracerebral hemorrhage,
degenerative neurologic diseases, meningitis, encephalitis, and head injury
with loss of consciousness) that may interfere with the interpretation of the
trial results, constitute a health risk for the patient, or that otherwise
renders the patient unsuitable for the trial according to the investigator*s
judgement.