Clinical trial NCT04479852: A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Sirtsei Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-21
Enrollment: 319
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 2 clinical study evaluating the safety and effectiveness of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent to participate in the study
* Males and females, aged 18 to 65 years
* In generally good physical health
* Body mass index (BMI) must be between 18 and 40 kg/m2
* Females of reproductive potential and males with partners of reproductive potential must agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of study drug
* Subjects must meet criteria for moderate to severe Major Depressive Disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI)
* Willing and able to comply with the study design schedule and other requirements

Exclusion Criteria:

* Female who is pregnant, breastfeeding, or less than six months postpartum at Screening
* History or presence of any clinically significant medical condition, disease, or surgical history that could jeopardize the safety of the subject or validity of the study data, or interfere with the absorption, distribution, metabolism, or excretion of the study drug
* Failure to discontinue all psychoactive medications or psychoactive supplements including antidepressants and mood stabilizers, within a time period prior to Baseline corresponding to at least five half-lives of the medication in question
* Presence of a clinically significant abnormality on physical examination or electrocardiogram (ECG), including a corrected QT interval using Fridericia's formula (QTcF) \>450 msec for males and \>470 msec for females
* Presence of uncontrolled hypertension, defined as consistent systolic blood pressure (SBP) \>160 mmHg or consistent 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, coagulation, and urinalysis)
* Screening liver function tests (ALT, AST, Alkaline phosphatase) \> 2x the upper limit of normal
* Subjects who, in the opinion of the Investigator, are not suitable candidates for the study

Primary outcomes:
measure: Change From Baseline to Week 4 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Change From Baseline to Week 4 in Clinical Global Impression - Severity (CGI-S) Total Score
timeFrame: Baseline to Week 4
measure: Change From Baseline to Week 4 in the 17-item Hamilton Depression Rating Scale (HAM D-17) Total Score
timeFrame: Baseline to Week 4
measure: Change From Baseline to Week 4 in the Sheehan Disability Scale (SDS)
timeFrame: Baseline to Week 4
measure: Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR)
timeFrame: Baseline to Week 4
measure: Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
timeFrame: Baseline to Week 4
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Alea Research
state: Arizona
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest
state: Arkansas
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Research
state: California
city: Colorado Springs
country: United States
facility: MCB Clinical Research Centers
state: Colorado
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Lauderhill
country: United States
facility: Innovative Clinical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Alpharetta
country: United States
facility: Institute for Advanced Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Chicago
country: United States
facility: American Medical Research
state: Illinois
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Saint Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Las Vegas
country: United States
facility: Altea Research Institute
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Brooklyn
country: United States
facility: SPRI Clinical Trials
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Hickory
country: United States
facility: Clinical Trials of America
state: North Carolina
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
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: Houston
country: United States
facility: Red Oak Psychiatry Associates
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: