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

Sponsor
Sirtsei Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04479852
Collaborator
(none)
319
39
2
20.9
8.2
0.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
319 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 30, 2020
Actual Primary Completion Date :
Jun 27, 2022
Actual Study Completion Date :
Jun 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: SP-624

Daily oral capsule, 20 mg/day

Drug: SP-624
Oral capsule

Placebo Comparator: Placebo

Daily oral capsule

Drug: Placebo
Oral capsule

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline to Week 4 in Montgomery Asberg Depression Rating Scale (MADRS) total score [Up to 4 weeks]

    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

  1. Change from Baseline to Weeks 1, 2, and 3 in Montgomery Asberg Depression Rating Scale total score [Up to 3 weeks]

    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.

  2. Change from Baseline to Weeks 1, 2, 3, and 4 in Clinical Global Impression - Severity (CGI-S) total score [Up to 4 weeks]

    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".

  3. Change from Baseline to Week 5 and change from Week 4 to Week 5 in MADRS total score [Up to 5 weeks]

    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.

  4. Change from Baseline to Week 5 and change from Week 4 to Week 5 in CGI-S total score [Up to 5 weeks]

    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".

  5. Change from Baseline to Week 2 and Week 4 in the 17-item Hamilton Depression Rating Scale (HAM D-17) total score [Up to 4 weeks]

    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.

  6. Change from Baseline to Week 2 and Week 4 in the Sheehan Disability Scale (SDS) [Up to 4 weeks]

    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.

  7. Change from Baseline to Week 2 and Week 4 in the Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR) [Up to 4 weeks]

    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.

  8. Change from Baseline to Week 2 and Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) [Up to 4 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alea Research Phoenix Arizona United States 85012
2 Woodland International Research Group Little Rock Arkansas United States 72211
3 Woodland Research Northwest Rogers Arkansas United States 72758
4 Collaborative Neuroscience Research Garden Grove California United States 92845
5 Pacific Research Partners Oakland California United States 94607
6 Artemis Institute for Clinical Research San Diego California United States 92103
7 Collaborative Neuroscience Research Torrance California United States 90502
8 MCB Clinical Research Centers Colorado Springs Colorado United States 80910
9 Sarkis Clinical Trials Gainesville Florida United States 32607
10 Clinical Neuroscience Solutions, Inc. Jacksonville Florida United States 32256
11 Innovative Clinical Research Lauderhill Florida United States 33319
12 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32801
13 Institute for Advanced Medical Research Alpharetta Georgia United States 30022
14 Atlanta Center for Medical Research Atlanta Georgia United States 30331
15 iResearch Atlanta Decatur Georgia United States 30030
16 American Medical Research Chicago Illinois United States 60612
17 Capstone Clinical Research Libertyville Illinois United States 60048
18 CBH Health Gaithersburg Maryland United States 20877
19 Midwest Research Group Saint Charles Missouri United States 63304
20 Altea Research Institute Las Vegas Nevada United States 89102
21 Hassman Research Institute Berlin New Jersey United States 08009
22 Center for Emotional Fitness Cherry Hill New Jersey United States 08002
23 Hassman Research Institute Marlton New Jersey United States 08053
24 SPRI Clinical Trials Brooklyn New York United States 11235
25 Manhattan Behavioral Medicine New York New York United States 10036
26 Richmond Behavioral Associates Staten Island New York United States 10312
27 New Hope Clinical Research Charlotte North Carolina United States 28211
28 Clinical Trials of America Hickory North Carolina United States 28601
29 Midwest Clinical Research Center Dayton Ohio United States 45417
30 Cutting Edge Research Group Oklahoma City Oklahoma United States 73116
31 Oregon Center for Clinical Investigations Portland Oregon United States 97214
32 Oregon Center for Clinical Investigations Salem Oregon United States 97301
33 Lehigh Center for Clinical Research Allentown Pennsylvania United States 18104
34 Clinical Neuroscience Solutions, Inc. Memphis Tennessee United States 38119
35 Donald J. Garcia, Jr., MD, PA Austin Texas United States 78737
36 Future Search Trials of Dallas Dallas Texas United States 75231
37 Red Oak Psychiatry Associates Houston Texas United States 77090
38 Grayline Research Center Wichita Falls Texas United States 76309
39 Core Clinical Research Everett Washington United States 98201

Sponsors and Collaborators

  • Sirtsei Pharmaceuticals, Inc.

Investigators

  • Study Director: Greg Rigdon, PhD, Sirtsei Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sirtsei Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT04479852
Other Study ID Numbers:
  • SP-624-201
First Posted:
Jul 21, 2020
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022