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| Name | Class |
|---|---|
| Rho, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP-624 | Experimental | Participants to receive two 10 mg capsules of SP-624 once daily for a total daily dose of 20 mg |
|
| Placebo | Placebo Comparator | Participant to receive 2 matching placebo capsules once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP-624 | Drug | Once daily oral administration of two capsules totaling 20 mg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greg Rigdon, PhD | Sirtsei Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMA Clinical Research | Phoenix | Arizona | 85012 | United States | ||
| Noble Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41099447 | Derived | Raskin J, Clayton AH, Kornstein SG, Papakostas GI, Prescott Y, Abernathy K, Hall J, Ackermann M, Wargin W, Rigdon G; SP-624-201 study investigators. A phase 2, multicenter, double-blind, randomized, placebo-controlled study of the safety and efficacy of forvisirvat (SP-624) in the treatment of adults with major depressive disorder. Curr Med Res Opin. 2025 Sep;41(9):1723-1734. doi: 10.1080/03007995.2025.2574465. Epub 2025 Oct 29. |
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| Placebo |
| Drug |
Once daily oral administration of two matching placebo capsules |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Tucson |
| Arizona |
| 85704 |
| United States |
| SanRo Clinical Research Group | Bryant | Arkansas | 72022 | United States |
| Clinical Innovations | Bellflower | California | 90706 | United States |
| Sun Valley Research Center | Imperial | California | 92251 | United States |
| Synergy San Diego | Lemon Grove | California | 91945 | United States |
| Excell Research | Oceanside | California | 92056 | United States |
| CiTrials | Riverside | California | 92506 | United States |
| Collaborative Neuroscience Research | Torrance | California | 90504 | United States |
| Sunwise Clinical Research | Walnut Creek | California | 94596 | United States |
| Next Level Clinical Trials | West Covina | California | 91790 | United States |
| MCB Clinical Research Centers | Colorado Springs | Colorado | 80910 | United States |
| Clinical Neuroscience Solutions | Jacksonville | Florida | 32256 | United States |
| Accel Clinical | Lakeland | Florida | 33803 | United States |
| Segal Trials | Lauderhill | Florida | 33319 | United States |
| Segal Trials - Miami Lakes | Miami Lakes | Florida | 33016 | United States |
| Clinical Neuroscience Solutions | Orlando | Florida | 32801 | United States |
| DMI Research | Pinellas Park | Florida | 33782 | United States |
| Accelerated Enrollment Solutions | Atlanta | Georgia | 30328 | United States |
| Velocity Clinical Research | Meridian | Idaho | 83642 | United States |
| Revive Research Institute | Elgin | Illinois | 60123 | United States |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Neurobehavioral Medicine Group | Bloomfield Hills | Michigan | 48302 | United States |
| Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| Alivation Research | Lincoln | Nebraska | 68526 | United States |
| IMA Clinical Research | Las Vegas | Nevada | 89102 | United States |
| Redbird Research | Las Vegas | Nevada | 89119 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| CenExel HRI | Marlton | New Jersey | 08053 | United States |
| IMA Clinical Research | Albuquerque | New Mexico | 87109 | United States |
| Integrative Clinical Trials | Brooklyn | New York | 11229 | United States |
| Pioneer Clinical Research | New York | New York | 10016 | United States |
| Magnolia Clinical Research | Cary | North Carolina | 27511 | United States |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| New Hope Clinical Research | Charlotte | North Carolina | 28211 | United States |
| Velocity Clinical Research | Beachwood | Ohio | 44122 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| North Star Medical Research | Middleburg Heights | Ohio | 44130 | United States |
| Summit Headlands | Portland | Oregon | 97210 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Clinical Neuroscience Solutions | Memphis | Tennessee | 38119 | United States |
| Donald J. Garcia, Jr, MD, PA | Austin | Texas | 78737 | United States |
| Future Search Trials of Dallas | Dallas | Texas | 75231 | United States |
| Haracec Clinical Research | El Paso | Texas | 79902 | United States |
| Pillar Clinical Research | Richardson | Texas | 75080 | United States |
| R and H Clinical Research | Stafford | Texas | 77477 | United States |
| Grayline Research Center | Wichita Falls | Texas | 76309 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Core Clinical Research | Everett | Washington | 98201 | United States |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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