Major Depressive DisorderPhase 2NCT06254612
A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
A Phase 2 study testing SP-624 in people with Major Depressive Disorder, run by Sirtsei Pharmaceuticals, Inc. at 50 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- SP-624
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 497 participants
- Where
- 50 sitesUnited States
- Study dates
- 25 Mar 2024to 8 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, aged 18 to 65 years, inclusive.
- Meet DSM-5 criteria for moderate to severe MDD, as confirmed by the Mini International Neuropsychiatric Interview (MINI).
- In generally good physical health, in the opinion of the Investigator.
- Body mass index (BMI) must be ≥ 18 and ≤ 45 kg/m2.
Who cannot join
- Female who is pregnant, breastfeeding, or less than 6 months postpartum at screen.
- A history of or current DSM-5 diagnosis of MDD with psychotic features, any schizophrenia spectrum and other psychotic disorders, bipolar disorder, or personality disorder.
- Presence or history of any known clinically significant cardiovascular disorders including, but not limited to: coronary artery disease, heart failure, valvular heart disease, cardiomyopathies, myocardial infarction, chamber enlargement or hypertrophy, or orthostatic hypotension.
- Presence of uncontrolled hypertension, defined as consistent sitting systolic blood pressure (SBP) >160 mmHg or consistent sitting 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, thyroid function, and urinalysis).
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
IMA Clinical Research
Albuquerque, New Mexico, 87109
Accelerated Enrollment Solutions
Atlanta, Georgia, 30328
Donald J. Garcia, Jr, MD, PA
Austin, Texas, 78737
Velocity Clinical Research
Beachwood, Ohio, 44122
Northwest Clinical Research Center
Bellevue, Washington, 98007
Clinical Innovations
Bellflower, California, 90706
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302
Boston Clinical Trials
Boston, Massachusetts, 02131
Integrative Clinical Trials
Brooklyn, New York, 11229
SanRo Clinical Research Group
Bryant, Arkansas, 72022
Magnolia Clinical Research
Cary, North Carolina, 27511
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
New Hope Clinical Research
Charlotte, North Carolina, 28211
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910
Future Search Trials of Dallas
Dallas, Texas, 75231
Midwest Clinical Research Center
Dayton, Ohio, 45417
Haracec Clinical Research
El Paso, Texas, 79902
Revive Research Institute
Elgin, Illinois, 60123
Core Clinical Research
Everett, Washington, 98201
Sun Valley Research Center
Imperial, California, 92251
Clinical Neuroscience Solutions
Jacksonville, Florida, 32256
Accel Clinical
Lakeland, Florida, 33803
IMA Clinical Research
Las Vegas, Nevada, 89102
Redbird Research
Las Vegas, Nevada, 89119
Segal Trials
Lauderhill, Florida, 33319
Synergy San Diego
Lemon Grove, California, 91945
Alivation Research
Lincoln, Nebraska, 68526
CenExel HRI
Marlton, New Jersey, 08053
Tandem Clinical Research
Marrero, Louisiana, 70072
Clinical Neuroscience Solutions
Memphis, Tennessee, 38119
Velocity Clinical Research
Meridian, Idaho, 83642
Segal Trials - Miami Lakes
Miami Lakes, Florida, 33016
North Star Medical Research
Middleburg Heights, Ohio, 44130
Pioneer Clinical Research
New York, New York, 10016
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Excell Research
Oceanside, California, 92056
Clinical Neuroscience Solutions
Orlando, Florida, 32801
IMA Clinical Research
Phoenix, Arizona, 85012
DMI Research
Pinellas Park, Florida, 33782
Summit Headlands
Portland, Oregon, 97210
Pillar Clinical Research
Richardson, Texas, 75080
CiTrials
Riverside, California, 92506
Midwest Research Group
Saint Charles, Missouri, 63304
R and H Clinical Research
Stafford, Texas, 77477
Collaborative Neuroscience Research
Torrance, California, 90504
Noble Clinical Research
Tucson, Arizona, 85704
Sunwise Clinical Research
Walnut Creek, California, 94596
Next Level Clinical Trials
West Covina, California, 91790
Grayline Research Center
Wichita Falls, Texas, 76309
About this study
Official title: A Multi-center, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
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.
- Conditions
- Major Depressive Disorder
- Being tested
- SP-624, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-624Drug
Once daily oral administration of two capsules totaling 20 mg/day
PlaceboDrug
Once daily oral administration of two matching placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| SP-624 | Experimental | Participants to receive two 10 mg capsules of SP-624 once daily for a total daily dose of 20 mg Receives: Drug: SP-624 |
| Placebo | Placebo comparator | Participant to receive 2 matching placebo capsules once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 4
Secondary outcomes (7)
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".
Measured: Baseline to Weeks 1-4 and 1- and 2- Week Follow-up
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Weeks 1-4 and 1- and 2- Week Follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start25 Mar 2024
- Primary completion8 Jul 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirtsei Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rho, Inc.
- Responsible party
- Sponsor
- Investigators
- Greg Rigdon, PhD, Study director, Sirtsei Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254612
- Sponsor's protocol ID
- SP-624-202
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41099447
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06254612
- Acronym / sponsor ID
- SP-624-202
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Sirtsei Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rho, Inc.
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 8 Jul 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP-624 | Experimental | Drug: SP-624Participants to receive two 10 mg capsules of SP-624 once daily for a total daily dose of 20 mg |
| Placebo | Placebo comparator | Drug: PlaceboParticipant to receive 2 matching placebo capsules once daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, aged 18 to 65 years, inclusive.
- Meet DSM-5 criteria for moderate to severe MDD, as confirmed by the Mini International Neuropsychiatric Interview (MINI).
- In generally good physical health, in the opinion of the Investigator.
- Body mass index (BMI) must be ≥ 18 and ≤ 45 kg/m2.
Key exclusion criteria (5 listed)
- Female who is pregnant, breastfeeding, or less than 6 months postpartum at screen.
- A history of or current DSM-5 diagnosis of MDD with psychotic features, any schizophrenia spectrum and other psychotic disorders, bipolar disorder, or personality disorder.
- Presence or history of any known clinically significant cardiovascular disorders including, but not limited to: coronary artery disease, heart failure, valvular heart disease, cardiomyopathies, myocardial infarction, chamber enlargement or hypertrophy, or orthostatic hypotension.
- Presence of uncontrolled hypertension, defined as consistent sitting systolic blood pressure (SBP) >160 mmHg or consistent sitting 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, thyroid function, and urinalysis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP-624Once daily oral administration of two capsules totaling 20 mg/day | Drug | SP-624 |
| PlaceboOnce daily oral administration of two matching placebo capsules | Drug | Placebo |
Primary outcome
Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.
Time frame: Baseline to Week 4
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.
7 secondary outcomes
Change from Baseline in the Clinical Global Impression - Severity (CGI-S) score.
Time frame: Baseline to Weeks 1-4 and 1- and 2- Week Follow-up
Change from Baseline in Quick Inventory of Depressive Symptomology-Self-Report (QIDS-SR) total score.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Weeks 2 and 4
Change from Baseline in Sheehan Disability Scale (SDS) total score.
Time frame: Baseline to Weeks 2 and 4
Change from Baseline in Symbol Digit Modalities Test (SDMT) score.
Time frame: 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.
Time frame: Baseline to Weeks 1-4 and 1- and 2- Week Follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Derived from this study: PubMed 41099447Raskin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Rigdon, PhD study director
Sirtsei Pharmaceuticals, Inc.
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SP-624 in people with Major Depressive Disorder, run by Sirtsei Pharmaceuticals, Inc. at 50 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06254612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.