A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
- Registration Number
- NCT06254612
- Lead Sponsor
- Sirtsei Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 456
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SP-624 SP-624 Participants to receive two 10 mg capsules of SP-624 once daily for a total daily dose of 20 mg Placebo Placebo Participant to receive 2 matching placebo capsules once daily
- Primary Outcome Measures
Name Time Method Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. Baseline to Week 4 The MADRS is a 10-item depression rating scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The toal score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.
- Secondary Outcome Measures
Name Time Method Change from Baseline in the Clinical Global Impression - Severity (CGI-S) score. Baseline to Weeks 1-4 and 1- and 2- Week Follow-up The CGI-S is a 7-point scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A score of 1 represents "normal" and 7 represents "most extremely ill".
Incidence rates of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to withdrawal from study. Baseline to Weeks 1-4 and 1- and 2- Week Follow up Change from Baseline in Quick Inventory of Depressive Symptomology-Self-Report (QIDS-SR) total score. Baseline to Weeks 1-4 and 1- and 2- Week Follow-up The QIDS-SR is a 16-item self-reported scale where each item has a 4-point scale where 0 represents least impact scores while 3 represents greatest impact scores. Some questions are linked. The total score ranges from 0 to 27 where a higher score indicates more depression.
Change from Baseline in Symbol Digit Modalities Test (SDMT) score. Baseline to Weeks 2 and 4 The SDMT is an assessment of complex scanning and visual tracking requiring elements of attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The SDMT measures the time to pair abstract symbols with specific numbers. The number of correct substitutions within 90 seconds is recorded and the total score is derived from the total number of correct responses with a minimum possible score of 0 and maximum of 110 where high scores indicate better outcome.
Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. Baseline to Weeks 1-3 and 1- and 2- Week Follow-up The MADRS is a 10-item depression rating scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The toal score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.
Change from Baseline in 17-item-Hamilton Depression Rating Scale (HAM-D-17) total score. Baseline to Weeks 2 and 4 The 17-item HAM-D is used to assess the severity of depression. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=No difficulty/absent and 4=most severe. The total score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression.
Change from Baseline in Sheehan Disability Scale (SDS) total score. Baseline to Weeks 2 and 4 The SDS is a 3-part scale that measures the degree of disruption on work, social and family life using an 11-point scale where 0 represents "no disruption" and 10 represents "extreme disruption". In addition to the 11-point scale, participants are asked to indicate the number of days in the past week that were "lost" and numbers of days that were "underproductive". The results of these questions have a range from 0 to 7. A total global functioning impairment score can be utilized by summing the scores from work, social and family life scales for a value range from 0 to 30.
Trial Locations
- Locations (39)
IMA Clinical Research
🇺🇸Albuquerque, New Mexico, United States
SanRo Clinical Research Group
🇺🇸Bryant, Arkansas, United States
Clinical Innovations
🇺🇸Bellflower, California, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
Sunwise Clinical Research
🇺🇸Lafayette, California, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
Excell Research
🇺🇸Oceanside, California, United States
CiTrials
🇺🇸Riverside, California, United States
Collaborative Neuroscience Research
🇺🇸Torrance, California, United States
Next Level Clinical Trials
🇺🇸West Covina, California, United States
MCB Clinical Research Centers
🇺🇸Colorado Springs, Colorado, United States
Clinical Neuroscience Solutions
🇺🇸Memphis, Tennessee, United States
Accel Clinical
🇺🇸Lakeland, Florida, United States
Segal Trials
🇺🇸Lauderhill, Florida, United States
Segal Trials - Miami Lakes
🇺🇸Miami Lakes, Florida, United States
DMI Research
🇺🇸Pinellas Park, Florida, United States
Accelerated Enrollment Solutions
🇺🇸Atlanta, Georgia, United States
Velocity Clinical Research
🇺🇸Beachwood, Ohio, United States
Revive Research Institute
🇺🇸Elgin, Illinois, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Alivation Research
🇺🇸Lincoln, Nebraska, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
CenExel HRI
🇺🇸Marlton, New Jersey, United States
Integrative Clinical Trials
🇺🇸Brooklyn, New York, United States
Pioneer Clinical Research
🇺🇸New York, New York, United States
Magnolia Clinical Research
🇺🇸Cary, North Carolina, United States
UNC Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
New Hope Clinical Research
🇺🇸Charlotte, North Carolina, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
North Star Medical Research
🇺🇸Middleburg Heights, Ohio, United States
Summit Headlands
🇺🇸Portland, Oregon, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Donald J. Garcia, Jr, MD, PA
🇺🇸Austin, Texas, United States
Future Search Trials of Dallas
🇺🇸Dallas, Texas, United States
Haracec Clinical Research
🇺🇸El Paso, Texas, United States
Pillar Clinical Research
🇺🇸Richardson, Texas, United States
R and H Clinical Research
🇺🇸Stafford, Texas, United States
Grayline Research Center
🇺🇸Wichita Falls, Texas, United States
Core Clinical Research
🇺🇸Everett, Washington, United States