Clinical trial NCT06254612: A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
Official title: A Multi-center, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Sirtsei Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rho, Inc.
First posted: 2024-02-12
Enrollment: 456
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 Phase 2B clinical study evaluating the effectiveness and safety of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.


Eligibility criteria: Key Inclusion Criteria:

* Males and females, aged 18 to 65 years, inclusive.
* Meet DSM-5 criteria for moderate to severe MDD, as confirmed by the Mini International Neuropsychiatric Interview (MINI).
* In generally good physical health, in the opinion of the Investigator.
* Body mass index (BMI) must be ≥ 18 and ≤ 45 kg/m2.

Key Exclusion Criteria:

* Female who is pregnant, breastfeeding, or less than 6 months postpartum at screen.
* A history of or current DSM-5 diagnosis of MDD with psychotic features, any schizophrenia spectrum and other psychotic disorders, bipolar disorder, or personality disorder.
* Presence or history of any known clinically significant cardiovascular disorders including, but not limited to: coronary artery disease, heart failure, valvular heart disease, cardiomyopathies, myocardial infarction, chamber enlargement or hypertrophy, or orthostatic hypotension.
* Presence of uncontrolled hypertension, defined as consistent sitting systolic blood pressure (SBP) \>160 mmHg or consistent sitting diastolic blood pressure (DBP) \>95 mmHg despite present therapy.
* Screening laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the Investigator (clinical chemistry, hematology, thyroid function, and urinalysis).

Primary outcomes:
measure: Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Change from Baseline in the Clinical Global Impression - Severity (CGI-S) score.
timeFrame: Baseline to Weeks 1-4 and 1- and 2- Week Follow-up
measure: Change from Baseline in Quick Inventory of Depressive Symptomology-Self-Report (QIDS-SR) total score.
timeFrame: Baseline to Weeks 1-4 and 1- and 2- Week Follow-up
measure: Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.
timeFrame: Baseline to Weeks 1-3 and 1- and 2- Week Follow-up
measure: Change from Baseline in 17-item-Hamilton Depression Rating Scale (HAM-D-17) total score.
timeFrame: Baseline to Weeks 2 and 4
measure: Change from Baseline in Sheehan Disability Scale (SDS) total score.
timeFrame: Baseline to Weeks 2 and 4
measure: Change from Baseline in Symbol Digit Modalities Test (SDMT) score.
timeFrame: Baseline to Weeks 2 and 4
measure: Incidence rates of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to withdrawal from study.
timeFrame: Baseline to Weeks 1-4 and 1- and 2- Week Follow up
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: IMA Clinical Research
state: Arizona
city: Bryant
country: United States
facility: SanRo Clinical Research Group
state: Arkansas
city: Bellflower
country: United States
facility: Clinical Innovations
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Riverside
country: United States
facility: CiTrials
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Research
state: California
city: West Covina
country: United States
facility: Next Level Clinical Trials
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers
state: Colorado
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Lakeland
country: United States
facility: Accel Clinical
state: Florida
city: Lauderhill
country: United States
facility: Segal Trials
state: Florida
city: Miami Lakes
country: United States
facility: Segal Trials - Miami Lakes
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research
state: Florida
city: Atlanta
country: United States
facility: Accelerated Enrollment Solutions
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research
state: Idaho
city: Elgin
country: United States
facility: Revive Research Institute
state: Illinois
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Lincoln
country: United States
facility: Alivation Research
state: Nebraska
city: Las Vegas
country: United States
facility: IMA Clinical Research
state: Nevada
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Marlton
country: United States
facility: CenExel HRI
state: New Jersey
city: Albuquerque
country: United States
facility: IMA Clinical Research
state: New Mexico
city: Brooklyn
country: United States
facility: Integrative Clinical Trials
state: New York
city: New York
country: United States
facility: Pioneer Clinical Research
state: New York
city: Cary
country: United States
facility: Magnolia Clinical Research
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Beachwood
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research
state: Ohio
city: Portland
country: United States
facility: Summit Headlands
state: Oregon
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions
state: Tennessee
city: Austin
country: United States
facility: Donald J. Garcia, Jr, MD, PA
state: Texas
city: Dallas
country: United States
facility: Future Search Trials of Dallas
state: Texas
city: El Paso
country: United States
facility: Haracec Clinical Research
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Research
state: Texas
city: Stafford
country: United States
facility: R and H Clinical Research
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Research Center
state: Texas
city: Everett
country: United States
facility: Core Clinical Research
state: Washington
Study officials:
affiliation: Sirtsei Pharmaceuticals, Inc.
name: Greg Rigdon, PhD
role: STUDY_DIRECTOR
References: