Clinical trial NCT06429722: To Evaluate the Effects of NMRA-335140 on Symptoms of Major Depression in Participants With Bipolar II Disorder.
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Effects of Oral NMRA-335140 Versus Placebo in Participants With a Major Depressive Episode Associated With Bipolar II Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Major Depressive Episode Associated With Bipolar II Disorder
Keywords: NMRA-335140
Navacaprant
BTRX-335140
CYM-53093
Bipolar II Disorder
Major Depressive Episode
Placebo-controlled
Double-blind
NMRA335140
NMRA 335140
Lead sponsor: Neumora Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled pilot study aiming to evaluate the effects of NMRA-335140 on symptoms of major depression in adults with Bipolar (BP) II disorder. The study design consists of a Screening Period (up to 28 days), a 6-week Treatment Period (during which participants will receive either NMRA-335140 or placebo), and a 6-week Safety Follow-up Period.


Eligibility criteria: Inclusion Criteria:

1. Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of BP II disorder with a current major depressive episode (MDE), without psychotic features confirmed by Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID-5-CT) at screening (this may be a first or recurrent episode).
2. Participant's current MDE and lifetime history of hypomanic episodes must be confirmed by independent assessment.
3. The symptoms of the current MDE have been present for more than 4 weeks prior to the Screening Visit, but no longer than 12 months prior to the Screening Visit.
4. Have a MADRS total score of 25 or higher at Screening and Baseline.
5. A change in MADRS total score between Screening and Baseline of ≤20%.

Exclusion Criteria:

1. Have failed 2 or more courses of antidepressant (adequate dose and duration, i.e., minimum 6 weeks) or mood stabilizer/antipsychotic treatment (each or in combination) for treatment of depressive symptoms in the current MDE.
2. Have currently or in the past year any of the following DSM-5-TR disorders: bipolar episodes with mixed features (including the current MDE), bipolar II with rapid cycling pattern (4 or more distinct mood episodes during a 12-month period). Participants with comorbid generalized anxiety disorder, social anxiety disorder, simple phobias, panic disorder, for whom bipolar II MDE is considered the primary diagnosis are not excluded.
3. Have a lifetime diagnosis of bipolar I disorder (manic episode schizophrenia, schizoaffective disorder, schizophreniform disorder, anorexia nervosa, bulimia nervosa, cluster B personality disorder, post-traumatic stress disorder (PTSD), or obsessive- compulsive disorder.
4. Have moderate to severe substance or alcohol use disorder, per DSM-5-TR criteria, within the 12 months prior to screening (excluding nicotine).
5. Are actively suicidal (e.g., any suicide attempts within the past 12 months) or are at serious suicidal risk as indicated by any current suicidal intent, including a plan, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) (score of "YES" on suicidal ideation Item 4 or 5 within 3 months prior to Visit 1 \[screening\]) and/or based on clinical evaluation by the Investigator; or are homicidal, in the opinion of the Investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Change from Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
timeFrame: Baseline and up to Week 6
Secondary outcomes:
measure: Change from Baseline to Week 6 assessed in the Snaith-Hamilton Pleasure Scale (SHAPS) total score
timeFrame: Baseline and up to Week 6
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Neumora Investigator Site
state: Arizona
city: Little Rock
country: United States
facility: Neumora Investigator Site
state: Arkansas
city: Garden Grove
country: United States
facility: Neumora Investigator Site
state: California
city: Long Beach
country: United States
facility: Neumora Investigator Site
state: California
city: San Jose
country: United States
facility: Neumora Investigator Site
state: California
city: Torrance
country: United States
facility: Neumora Investigator Site
state: California
city: Gainesville
country: United States
facility: Neumora Investigator Site
state: Florida
city: Lauderhill
country: United States
facility: Neumora Investigator Site
state: Florida
city: Maitland
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami Lakes
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Marietta
country: United States
facility: Neumora Investigator Site
state: Georgia
city: Savannah
country: United States
facility: Neumora Investigator Site
state: Georgia
city: Watertown
country: United States
facility: Neumora Investigator Site
state: Massachusetts
city: Flowood
country: United States
facility: Neumora Investigator Site
state: Mississippi
city: Marlton
country: United States
facility: Neumora Investigator Site
state: New Jersey
city: Princeton
country: United States
facility: Neumora Investigator Site
state: New Jersey
city: Toms River
country: United States
facility: Neumora Investigator Site
state: New Jersey
city: Brooklyn
country: United States
facility: Neumora Investigator Site
state: New York
city: Houston
country: United States
facility: Neumora Investigator Site
state: Texas
city: Bellevue
country: United States
facility: Neumora Investigator Site
state: Washington
Study officials:
References: