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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479852
• Other study ID #: SP-624-201
• Status: Completed
• Phase: Phase 2
• Start date: September 30, 2020
• Est. completion date: June 27, 2022

Study information

• Verified date: June 2023
• Source: Sirtsei Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: June 27, 2022
• Est. primary completion date: June 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• SP-624
Oral capsule
• Placebo
Oral capsule

Locations

Country	Name	City	State
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Institute for Advanced Medical Research	Alpharetta	Georgia
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Donald J. Garcia, Jr., MD, PA	Austin	Texas
United States	Hassman Research Institute	Berlin	New Jersey
United States	SPRI Clinical Trials	Brooklyn	New York
United States	New Hope Clinical Research	Charlotte	North Carolina
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	American Medical Research	Chicago	Illinois
United States	MCB Clinical Research Centers	Colorado Springs	Colorado
United States	Future Search Trials of Dallas	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	iResearch Atlanta	Decatur	Georgia
United States	Core Clinical Research	Everett	Washington
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	CBH Health	Gaithersburg	Maryland
United States	Collaborative Neuroscience Research	Garden Grove	California
United States	Clinical Trials of America	Hickory	North Carolina
United States	Red Oak Psychiatry Associates	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Altea Research Institute	Las Vegas	Nevada
United States	Innovative Clinical Research	Lauderhill	Florida
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Hassman Research Institute	Marlton	New Jersey
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Manhattan Behavioral Medicine	New York	New York
United States	Pacific Research Partners	Oakland	California
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Alea Research	Phoenix	Arizona
United States	Oregon Center for Clinical Investigations	Portland	Oregon
United States	Woodland Research Northwest	Rogers	Arkansas
United States	Midwest Research Group	Saint Charles	Missouri
United States	Oregon Center for Clinical Investigations	Salem	Oregon
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Collaborative Neuroscience Research	Torrance	California
United States	Grayline Research Center	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sirtsei Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Week 4 in Montgomery Asberg Depression Rating Scale (MADRS) total score	The Montgomery Asberg Depression rating scale is a 10-item scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The total score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.	Up to 4 weeks
Secondary	Change from Baseline to Weeks 1, 2, and 3 in Montgomery Asberg Depression Rating Scale total score	The Montgomery Asberg Depression rating scale is a 10-item scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The total score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.	Up to 3 weeks
Secondary	Change from Baseline to Weeks 1, 2, 3, and 4 in Clinical Global Impression - Severity (CGI-S) total 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".	Up to 4 weeks
Secondary	Change from Baseline to Week 5 and change from Week 4 to Week 5 in MADRS total score	The Montgomery Asberg Depression rating scale is a 10-item scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The total score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.	Up to 5 weeks
Secondary	Change from Baseline to Week 5 and change from Week 4 to Week 5 in CGI-S total 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".	Up to 5 weeks
Secondary	Change from Baseline to Week 2 and Week 4 in the 17-item Hamilton Depression Rating Scale (HAM D-17) total score	The 17-item Hamilton Depression rating scale 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.	Up to 4 weeks
Secondary	Change from Baseline to Week 2 and Week 4 in the Sheehan Disability Scale (SDS)	The Sheehan Disability Scale 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 "unproductive". 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.	Up to 4 weeks
Secondary	Change from Baseline to Week 2 and Week 4 in the Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR)	The Quick Inventory of Depressive Symptomology - Self Report (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.	Up to 4 weeks
Secondary	Change from Baseline to Week 2 and Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)	The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item satisfaction scale where each item has a 5-point scale. A score of 1 represents "very poor satisfaction", while a score of 5 represents "very good satisfaction". Only the first 14 items are summed for a total score that ranges from 14 to 70.	Up to 4 weeks