Major depressive disorder MedDRA version: 20.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: rapastinel
Product Code: AGN-241659 (previously GLYX-13)
Pharmaceutical Form: Solution for infusion in pre-filled syringe
INN or Proposed INN: RAPASTINEL
Current Sponsor code: AGN-241659
Sponsors
Allergan Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Male and female outpatients who are 18 to 75 years of age ?Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD (based on confirmation from the Structured Clinical Interview for Diagnostic Statistic Manual of Mental Health Disorders, Fifth Edition [SCID]), with a current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1 ?Have a minimum score of 26 on the rater-administered Montgomery-Åsberg Depression Rating Scale (MADRS) and a minimum score of 24 on the computer administered MADRS at screening (Visit 1) and baseline (Visit 2) ?Have a Clinical Global Impressions - Severity (CGI-S) score of = 4 at screening and baseline ?Inadequate response (=65 years) yes F.1.3.1 Number of subjects for this age range 69
Exclusion criteria
Exclusion criteria: ?DSM-5–based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1. Comorbid generalized anxiety disorder, social anxiety disorder, or specific phobias are acceptable provided they play a secondary role in the balance of symptoms and are not the primary driver of treatment decisions. ? Lifetime history of meeting DSM-5 criteria for: a. Schizophrenia spectrum or other psychotic disorder b. Bipolar or related disorder c. Major neurocognitive disorder d. Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the patient’s ability to consent, follow study directions, or otherwise safely participate in the study e. Dissociative disorder f. Posttraumatic stress disorder g. MDD with psychotic features ?History of meeting DSM-5 criteria for alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before Visit 1 ? DSM-5–based diagnosis of any personality disorder of sufficient severity to interfere with participation in this study in the opinion of the investigator ? History (based on patient report, medical records, and investigator judgement) of: a. Inadequate response to electroconvulsive therapy (ECT), a monoamine oxidase inhibitor or ketamine b. Treatment with clozapine or any depot antipsychotic (exception: episodic use of clozapine at doses = 150 mg/day for the treatment of insomnia) c. ECT, vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the 6 months before Visit 1 (whichever is longer) d. Tardive dyskinesia, serotonin syndrome, or neuroleptic malignant syndrome e. Intolerance or hypersensitivity to rapastinel or vortioxetine f. f. Inadequate response to previous treatment with vortioxetine at adequate doses and for adequate duration Other Medical Criteria ... 16. Females of childbearing potential and male partners of females of childbearing potential, not using a highly effective means of contraception (Section 9.4.10.2 and Appendix V for contraceptive guidance) ... 27. Known bleeding tendencies or related disorders ?Having received: a. Anticonvulsant/mood stabilizer, within 1 year prior to Visit 1 b. Antipsychotic in the current episode, with the exception of quetiapine = 50 mg/day or clozapine = 150 mg/day given for insomnia provided it can be safely discontinued prior to Visit 2 c. Treatment with lithium as an ADT augmentation agent in the current episode ? Positive result at Visit 1 from the urine drug screen (UDS) test for any prohibited medication. Exception: patients with a positive UDS at Visit 1 for opiates, cannabinoids or episodic use of benzodiazepines may be allowed in the study provided: a. The drug was used for a legitimate medical purpose (any recreational use is exclusionary); b. The drug can be discontinued prior to participation in the study (except for episodic use of benzodiazepines which may be continued); and c. A repeat UDS is negative for these substances prior to enrollment (except for episodic use of benzodiazepines which may be continued) ?Suicide risk, as determined by meeting any of the following criteria: a. A suicide attempt within the past year b. Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the C-SSRS at Visit 1 or Visit 2 c. MADRS Item 10 score = 5 at Visit 1 or Visit 2 on either the rater administered MADRS or computer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of rapastinel (450 mg IV) versus placebo and vortioxetine (10-20 mg oral) versus placebo in the treatment of MDD, as measured by the change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total score at end of treatment (end of week 6);Secondary Objective: To evaluate the efficacy of rapastinel (450 mg IV) versus placebo and vortioxetine (10-20 mg oral) versus placebo in the treatment of MDD, as measured by the change from baseline MADRS total score at 1 day post-first dose of treatment;Primary end point(s): Change from baseline in MADRS total score at the end of the DBTP (end of Week 6);Timepoint(s) of evaluation of this end point: After 6 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Endpoint Change from baseline in MADRS total score at 1 day after first dose of treatment Additional Endpoints •Change from baseline in MADRS at 7 days after first dose of treatment •Change from baseline in CGI-S at 1 and 7 days after first dose of treatment, and end of treatment (end of Week 6) •Rate of sustained responders during treatment •Rate of responders at 1 and 7 days after first dose of treatment, and end of treatment (end of Week 6) •Rate of sustained remitters during treatment •Rate of remitters at 1 and 7 days after first dose of treatment, and end of treatment (end of Week 6) •Time to first response •Time to first sustained response •Time to first remission •Time to first sustained remission •Change from baseline in Sheehan Disability Scale (SDS) at end of treatment (end of Week 6) •Change from baseline in Medication Satisfaction Questionnaire (MSQ) at end of treatment (end of Week 6);Timepoint(s) of evaluation of this end point: Key secondary endpoint: Change from baseline in MADRS total score at 1 day after first dose of investigational product (IP) Additional endpoints: At each visit and the final analysis will be done at the end of the study | — |
Countries
Bulgaria, Canada, Czech Republic, France, Germany, Italy, Russian Federation, Serbia, Spain, Sweden, Ukraine, United Kingdom
Contacts
Public ContactEU Global Clinical Trial Management
Allergan Ltd.
Outcome results
None listed