Clinical trial NCT06656416: ALTO-100 in Bipolar Disorder with Depression (BD-D)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Followed by Open-Label Treatment of ALTO-100 in Adults with Bipolar Disorder Currently Experiencing a Major Depressive Episode
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Bipolar Disorder I or II with a Major Depressive Episode
Keywords: Bipolar I
Bipolar II
Major Depressive Episode
Lead sponsor: Alto Neuroscience
Sponsor class: INDUSTRY
First posted: 2024-10-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of BD-I or BD-II as well as BD-D
* At baseline, taking a mood stabilizer, lithium (LI) or lamotrigine (LMG) or valproic acid (VPA, any form) or combination of Li + LMG or Li + VPA for at least 6 weeks with no dose modifications in the past 2 weeks
* Willing to comply with all study assessments and procedures
* Must not be pregnant or breastfeeding at time of enrollment or throughout study

Exclusion Criteria:

* Evidence of unstable medical condition
* Concurrent use of any prohibited medications or substance use disorder
* Diagnosed psychotic disorder (other than mania or depression)
* Current moderate or severe substance use disorder
* Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients
* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Primary outcomes:
measure: To assess efficacy of ALTO-100 versus placebo on depression symptoms in bipolar disorder in a pre-defined subgroup of participants as measured by the mean change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score
timeFrame: Change assessed from Day 1 to Week 6
Secondary outcomes:
measure: To assess efficacy of ALTO-100 vs placebo for self-reported depressive symptoms in bipolar disorder patients in a pre- defined subgroup of participants as measured by the change from Day 1 to Week 6 in Patient Health Questionnaire, 9 item (PHQ-9)
timeFrame: Assessed 4 times over a 6-week interval, from Day 1 to Week 6
measure: To assess efficacy of ALTO-100 vs placebo in severity of bipolar disorder symptoms in a pre-defined subgroup of participants as measured by the change from Day 1 to Week 6 in Clinician Global Impression Scale-severity (CGI-S)
timeFrame: Assessed 4 times over a 6-week interval, from Day 1 to Week 6
measure: To assess efficacy of ALTO-100 vs placebo for depressive symptoms in MDD in a pre-defined subgroup as measured by the change from Day 1 to Week 6 in response (>50% improvement from baseline) and remission (total score of <10) rates based on MADRS
timeFrame: Assessed 4 times over a 6-week interval, from Day 1 to Week 6
measure: To assess efficacy of ALTO-100 vs placebo on depressive symptoms in bipolar disorder in all randomized participants as measured by the change from Day 1 to Week 6 on the MADRS
timeFrame: Assessed 4 times over a 6-week interval, from Day 1 to Week 6
measure: To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of the incidence, severity, and relatedness of Treatment Emergent Adverse Events (TEAEs), SAEs, discontinuation due to TEAEs and deaths
timeFrame: Assessed from Day 1 to Week 13
measure: To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of Heart Rate in bpm
timeFrame: Assessed from Day 1 to Week 13
measure: To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of Blood Pressure in mmHg
timeFrame: Assessed from Day 1 to Week 13
measure: To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of Weight in pounds
timeFrame: Assessed from Day 1 to Week 13
measure: To evaluate the safety of ALTO-100 during both the DB and OL periods of the study as measured by the assessment of suicidality with the Concise Health Risk Tracking Self-Report,12 item scale (CHRT-SR12)
timeFrame: Assessed from Day 1 to Week 13
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Site 6036
state: Arizona
city: Phoenix
country: United States
facility: Site 6000
state: Arizona
city: Yuma
country: United States
facility: Site 6087
state: Arizona
city: Imperial
country: United States
facility: Site 6081
state: California
city: Oceanside
country: United States
facility: Site 6082
state: California
city: Lauderhill
country: United States
facility: Site 6067
state: Florida
city: Atlanta
country: United States
facility: Site 6068
state: Georgia
city: Peachtree Corners
country: United States
facility: Site 6064
state: Georgia
city: Baltimore
country: United States
facility: Site 6151
state: Maryland
city: Lincoln
country: United States
facility: Site 6142
state: Nebraska
city: Las Vegas
country: United States
facility: Site 6144
state: Nevada
city: Albuquerque
country: United States
facility: Site 6078
state: New Mexico
city: Westlake
country: United States
facility: Site 6075
state: Ohio
city: Houston
country: United States
facility: Site 6072
state: Texas
city: Draper
country: United States
facility: Site 6121
state: Utah
Study officials:
affiliation: Alto Neuroscience
name: Mallory Loflin, PhD
role: STUDY_DIRECTOR
References: