A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254612
• Other study ID #: SP-624-202
• Status: Recruiting
• Phase: Phase 2
• Start date: March 25, 2024
• Est. completion date: July 11, 2025

Study information

• Verified date: June 2024
• Source: Sirtsei Pharmaceuticals, Inc.
• Contact: Yuki Prescott
• Phone: 919-460-9500
• Email: yprescott[@]arrivobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 456
• Est. completion date: July 11, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• SP-624
Once daily oral administration of two capsules totaling 20 mg/day
• Placebo
Once daily oral administration of two matching placebo capsules

Locations

Country	Name	City	State
United States	IMA Clinical Research	Albuquerque	New Mexico
United States	Accelerated Enrollment Solutions	Atlanta	Georgia
United States	Donald J. Garcia, Jr, MD, PA	Austin	Texas
United States	Clinical Innovations	Bellflower	California
United States	CenExel HRI	Berlin	New Jersey
United States	Boston Clinical Trials	Boston	Massachusetts
United States	SanRo Clinical Research Group	Bryant	Arkansas
United States	New Hope Clinical Research	Charlotte	North Carolina
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Revive Research Institute	Elgin	Illinois
United States	Core Clinical Research	Everett	Washington
United States	Clinical Neuroscience Solutions	Jacksonville	Florida
United States	Sunwise Clinical Research	Lafayette	California
United States	Accel Clinical	Lakeland	Florida
United States	IMA Clinical Research	Las Vegas	Nevada
United States	Segal Trials	Lauderhill	Florida
United States	Synergy San Diego	Lemon Grove	California
United States	Clinical Neuroscience Solutions	Memphis	Tennessee
United States	Segal Trials - Miami Lakes	Miami Lakes	Florida
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Excell Research	Oceanside	California
United States	Clinical Neuroscience Solutions	Orlando	Florida
United States	IMA Clinical Research	Phoenix	Arizona
United States	Summit Headlands	Portland	Oregon
United States	Pillar Clinical Research	Richardson	Texas
United States	CiTrials	Riverside	California
United States	R and H Clinical Research	Stafford	Texas
United States	Collaborative Neuroscience Research	Torrance	California
United States	Grayline Research Center	Wichita Falls	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Sirtsei Pharmaceuticals, Inc.	Rho, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.	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.	Baseline to Week 4
Secondary	Change from Baseline in the Clinical Global Impression - Severity (CGI-S) score.	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".	Baseline to Weeks 1-4 and 1- and 2- Week Follow-up
Secondary	Change from Baseline in Quick Inventory of Depressive Symptomology-Self-Report (QIDS-SR) total score.	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.	Baseline to Weeks 1-4 and 1- and 2- Week Follow-up
Secondary	Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.	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.	Baseline to Weeks 1-3 and 1- and 2- Week Follow-up
Secondary	Change from Baseline in 17-item-Hamilton Depression Rating Scale (HAM-D-17) total score.	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.	Baseline to Weeks 2 and 4
Secondary	Change from Baseline in Sheehan Disability Scale (SDS) total score.	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.	Baseline to Weeks 2 and 4
Secondary	Change from Baseline in Symbol Digit Modalities Test (SDMT) score.	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.	Baseline to Weeks 2 and 4
Secondary	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