search
Back to results

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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SP-624
Placebo
Sponsored by
Sirtsei Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alea Research
  • Woodland International Research Group
  • Woodland Research Northwest
  • Collaborative Neuroscience Research
  • Pacific Research Partners
  • Artemis Institute for Clinical Research
  • Collaborative Neuroscience Research
  • MCB Clinical Research Centers
  • Sarkis Clinical Trials
  • Clinical Neuroscience Solutions, Inc.
  • Innovative Clinical Research
  • Clinical Neuroscience Solutions, Inc.
  • Institute for Advanced Medical Research
  • Atlanta Center for Medical Research
  • iResearch Atlanta
  • American Medical Research
  • Capstone Clinical Research
  • CBH Health
  • Midwest Research Group
  • Altea Research Institute
  • Hassman Research Institute
  • Center for Emotional Fitness
  • Hassman Research Institute
  • SPRI Clinical Trials
  • Manhattan Behavioral Medicine
  • Richmond Behavioral Associates
  • New Hope Clinical Research
  • Clinical Trials of America
  • Midwest Clinical Research Center
  • Cutting Edge Research Group
  • Oregon Center for Clinical Investigations
  • Oregon Center for Clinical Investigations
  • Lehigh Center for Clinical Research
  • Clinical Neuroscience Solutions, Inc.
  • Donald J. Garcia, Jr., MD, PA
  • Future Search Trials of Dallas
  • Red Oak Psychiatry Associates
  • Grayline Research Center
  • Core Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SP-624

Placebo

Arm Description

Daily oral capsule, 20 mg/day

Daily oral capsule

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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".
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.
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".
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.
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.
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.
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.

Full Information

First Posted
July 16, 2020
Last Updated
June 8, 2023
Sponsor
Sirtsei Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04479852
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
June 27, 2022 (Actual)
Study Completion Date
June 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sirtsei Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
319 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SP-624
Arm Type
Experimental
Arm Description
Daily oral capsule, 20 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily oral capsule
Intervention Type
Drug
Intervention Name(s)
SP-624
Intervention Description
Oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsule
Primary Outcome Measure Information:
Title
Change from Baseline to Week 4 in Montgomery Asberg Depression Rating Scale (MADRS) total score
Description
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.
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline to Weeks 1, 2, and 3 in Montgomery Asberg Depression Rating Scale total score
Description
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.
Time Frame
Up to 3 weeks
Title
Change from Baseline to Weeks 1, 2, 3, and 4 in Clinical Global Impression - Severity (CGI-S) total score
Description
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".
Time Frame
Up to 4 weeks
Title
Change from Baseline to Week 5 and change from Week 4 to Week 5 in MADRS total score
Description
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.
Time Frame
Up to 5 weeks
Title
Change from Baseline to Week 5 and change from Week 4 to Week 5 in CGI-S total score
Description
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".
Time Frame
Up to 5 weeks
Title
Change from Baseline to Week 2 and Week 4 in the 17-item Hamilton Depression Rating Scale (HAM D-17) total score
Description
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.
Time Frame
Up to 4 weeks
Title
Change from Baseline to Week 2 and Week 4 in the Sheehan Disability Scale (SDS)
Description
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.
Time Frame
Up to 4 weeks
Title
Change from Baseline to Week 2 and Week 4 in the Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR)
Description
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.
Time Frame
Up to 4 weeks
Title
Change from Baseline to Week 2 and Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Description
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.
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Rigdon, PhD
Organizational Affiliation
Sirtsei Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alea Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland Research Northwest
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Collaborative Neuroscience Research
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Pacific Research Partners
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Collaborative Neuroscience Research
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
MCB Clinical Research Centers
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Innovative Clinical Research
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Institute for Advanced Medical Research
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
iResearch Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
American Medical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
CBH Health
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Altea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Center for Emotional Fitness
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Hassman Research Institute
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
SPRI Clinical Trials
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Manhattan Behavioral Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
New Hope Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Clinical Trials of America
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Oregon Center for Clinical Investigations
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Facility Name
Oregon Center for Clinical Investigations
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Lehigh Center for Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Donald J. Garcia, Jr., MD, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Future Search Trials of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Red Oak Psychiatry Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Grayline Research Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs