A Study of Brexpiprazole Plus Ketamine in... — Clinical Trial Details

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

18 - 35

Psychosis History

Inclusion Criteria

Inclusion Criteria:
1. Male or female, 18 to 65 years of age, inclusive, at screening.
2. Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
3. Diagnosed with MDD, single or recurrent, and currently experiencing a major depressive episode (MDE) of at least eight weeks in duration, prior to screening, according to DSM-5. Diagnosis made by site psychiatrist and supported by the SCID-5; confirmed by remote independent raters with a SAFER interview.
4. History of treatment resistant depression (TRD) during the current MDE, as assessed by investigator and remote centralized rater using the MGH ATRQ. TRD defined as failure to achieve a satisfactory response (e.g., <50% improvement) to at least 2 'treatment courses' during the current episode of therapeutic-dose ADT of at least 8 weeks. Participants must be on a stable (≥4 weeks) and adequate (per MGH ATRQ) dose of ongoing ADT (except MAOIs), total duration at least 8 weeks.
5. MADRS total score >20 at both the screen visit and the baseline visit, confirmed by remote centralized rater.
6. In good general health based on medical history, physical exam, labs, and ECG.
7. If female, non-childbearing potential or use of acceptable birth control; negative pregnancy test at screening and baseline; willing to use contraception during study.
8. Body mass index between 18 and 35 kg/m2.
9. Concurrent psychotherapy allowed if stable for ≥3 months and expected to remain stable.
10. Concurrent hypnotic therapy allowed if stable for ≥4 weeks; benzodiazepines allowed if stable for ≥4 weeks.

Exclusion Criteria

Exclusion Criteria:
1. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
2. Female who is pregnant or breastfeeding.
3. Female with a positive pregnancy test at screening or baseline.
4. History during the current MDE of failure to achieve satisfactory response to >7 treatment courses of a therapeutic dose of an antidepressant therapy of at least 8 weeks duration, as confirmed by remote rater.
5. Total MADRS score of <20 at the screen visit or baseline visit, or as assessed by remote rater.
6. Current diagnosis of a substance use disorder (abuse or dependence), with the exception of nicotine dependence, at screening or within 6 months prior to screening.
7. Current Axis I disorder that is the principal focus of treatment and MDD secondary for the past 6 months or more.
8. History of bipolar disorder, schizophrenia or schizoaffective disorder, or any history of psychotic symptoms in current or previous depressive episodes.
9. History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within 5 years of screening.
10. Any Axis I or Axis II disorder clinically predominant to MDD at screening or within 6 months prior.
11. Investigator judgment that subject is at significant risk for suicidal behaviour during participation.
12. Failed to respond to ECT during the current depressive episode.
13. Prior VNS treatment.
14. Dementia, delirium, amnestic, or other cognitive disorder.
15. Clinically significant abnormality on screening physical exam that might affect safety or study participation.
16. Participation in any clinical trial with an investigational drug or device within the past month or concurrent participation.
17. Current episode of specified cardiovascular conditions (e.g., hypertension ≥160/100 mmHg at baseline, recent MI within 1 year, syncopal event within past year, CHF >NYHA Stage 2, angina, HR <45 or >110 bpm, QTcF ≥450 msec).
18. Chronic lung disease excluding asthma.
19. Lifetime history of major neurosurgery, encephalitis, meningitis, degenerative CNS disorder, epilepsy, intellectual disability, or significant head trauma within past 2 years.
20. Specified lab abnormalities or requirement for exclusionary concomitant medications.

Company

Product

Legal

A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD)

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Study Arms & Interventions

Ketamine/Brexpiprazole

Interventions

Ketamine/Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators