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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: SP-624
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SP-624<br>Daily oral capsule, 20 mg/day | Drug: SP-624<br>* Oral capsule<br>|
| Placebo Comparator: Placebo<br>Daily oral capsule | Drug: Placebo<br>* Oral capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |