Major Depressive DisorderPhase 1NCT06570369
A Study to Explore the Effect of SP-624 on Brain Network Analytics in Healthy Adults and Adults With Major Depression
A Phase 1 study testing SP-624 in people with Major Depressive Disorder and Depression, run by Sirtsei Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
The main goal of this clinical trial is to learn if the active study drug (code name: SP-624) has any effect on the electrical activity of the brain in adult healthy volunteers and in adults with major depression. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Depression, Healthy
- 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
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Aug 2024to 18 May 2026
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In generally good health
- Body mass index (BMI) between 18.0 and 40.0 kg/m2
- Willing to comply with the requirements of the study
- For participants with depression: must meet study criteria for moderate to severe major depressive disorder
Who cannot join
- Female who is pregnant or breastfeeding.
- Clinically significant health condition or clinically significant abnormal results on screening health tests
- For participants with depression: presence of exclusionary study criteria for co-morbid psychiatric conditions or medication history.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CenExel CNS
Garden Grove, California, 92845
Alivation Research
Lincoln, Nebraska, 68526
About this study
Official title: A Phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled Study to Explore the Effect of SP-624 on Brain Network Analytics in Cohorts of Healthy Adult Subjects and Subjects With Major Depressive Disorder
The main goal of this clinical trial is to learn if the active study drug (code name: SP-624) has any effect on the electrical activity of the brain in adult healthy volunteers and in adults with major depression. Another goal of the study is to learn if SP-624 improves memory and learning in adults with major depression. The study will also provide additional information on the safety of SP-624 and how well it is tolerated in adult healthy volunteers and adults with major depression.
Researchers will compare SP-624 to a placebo (a look-alike substance that contains no drug) to see if SP-624 has any effect on study tests.
Read more
Study participants will:
Take capsules of study drug (SP-624 or a placebo) once daily for 2 weeks; visit the clinic at Screening, Day 1 (first dose of study drug), and Day 15 (last dose of study drug) for checkups and tests; and have phone call check-ups on Day 7 and about 1 week after the last dose of study drug.
- Conditions
- Major Depressive Disorder, Depression, Healthy
- Being tested
- SP-624, Placebo
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-624Drug
Oral dose, once daily for 2 weeks
PlaceboDrug
Oral dose, once daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| SP-624 | Experimental | SP-624 oral capsule, once daily for 2 weeks Receives: Drug: SP-624 |
| Placebo | Placebo comparator | Placebo oral capsule, once daily for 2 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Network Analytics Profile
Brain activity using an electroencephalography (EEG) system during rest and while evoking specific brain activity response will be recorded, and artificial intelligence (AI) based analytics will be performed on the EEG recordings to provide a brain network analytic (BNA) profile for each study participant. The BNA profile at the Day 15 Visit will be compared to the BNA profile at Day 1 pre-dose to evaluate changes in the profile after 2 weeks of daily dosing with the assigned study intervention.
Measured: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention
Secondary outcomes (5)
Brain Network Analytics Profile
Brain activity using an electroencephalography (EEG) system during rest and while evoking specific brain activity response will be recorded, and artificial intelligence (AI) based analytics will be performed on the EEG recordings to provide a brain network analytic (BNA) profile for each study participant. The BNA profile at Day 1 post-dose will be compared to the BNA profile at Day 1 pre-dose to evaluate changes in the profile after a single dose of the assigned study intervention.
Measured: At the Day 1 Visit, completed on study day 1 after the first dose of the assigned study intervention
Spatial Working Memory Test
Measured: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)
Paired Associates Learning Test
Measured: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)
Digit Symbol Substitution Test
Measured: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)
Treatment Emergent Adverse Events
Measured: Through study completion, an average of 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start22 Aug 2024
- Primary completion11 May 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirtsei Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Raskin, MD, Study director, Sirtsei Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570369
- Sponsor's protocol ID
- SP-624-103
- Status last verified
- May 2026
- First submitted
- 17 Aug 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled Study to Explore the Effect of SP-624 on Brain Network Analytics in Cohorts of Healthy Adult Subjects and Subjects With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06570369
- Acronym / sponsor ID
- SP-624-103
- Conditions
- Major Depressive Disorder, Depression, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sirtsei Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 26 Aug 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.
The main goal of this clinical trial is to learn if the active study drug (code name: SP-624) has any effect on the electrical activity of the brain in adult healthy volunteers and in adults with major depression. Another goal of the study is to learn if SP-624 improves memory and learning in adults with major depression. The study will also provide additional information on the safety of SP-624 and how well it is tolerated in adult healthy volunteers and adults with major depression.
Researchers will compare SP-624 to a placebo (a look-alike substance that contains no drug) to see if SP-624 has any effect on study tests.
Study participants will:
Take capsules of study drug (SP-624 or a placebo) once daily for 2 weeks; visit the clinic at Screening, Day 1 (first dose of study drug), and Day 15 (last dose of study drug) for checkups and tests; and have phone call check-ups on Day 7 and about 1 week after the last dose of study drug.
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-624SP-624 oral capsule, once daily for 2 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral capsule, once daily for 2 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- In generally good health
- Body mass index (BMI) between 18.0 and 40.0 kg/m2
- Willing to comply with the requirements of the study
- For participants with depression: must meet study criteria for moderate to severe major depressive disorder
Key exclusion criteria (3 listed)
- Female who is pregnant or breastfeeding.
- Clinically significant health condition or clinically significant abnormal results on screening health tests
- For participants with depression: presence of exclusionary study criteria for co-morbid psychiatric conditions or medication history.
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-624Oral dose, once daily for 2 weeks | Drug | SP-624 |
| PlaceboOral dose, once daily for 2 weeks | Drug | Placebo |
Primary outcome
Brain Network Analytics Profile
Time frame: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention
Brain activity using an electroencephalography (EEG) system during rest and while evoking specific brain activity response will be recorded, and artificial intelligence (AI) based analytics will be performed on the EEG recordings to provide a brain network analytic (BNA) profile for each study participant. The BNA profile at the Day 15 Visit will be compared to the BNA profile at Day 1 pre-dose to evaluate changes in the profile after 2 weeks of daily dosing with the assigned study intervention.
5 secondary outcomes
Brain Network Analytics Profile
Time frame: At the Day 1 Visit, completed on study day 1 after the first dose of the assigned study intervention
Spatial Working Memory Test
Time frame: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)
Paired Associates Learning Test
Time frame: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)
Digit Symbol Substitution Test
Time frame: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention (Participants with Depression Only)
Treatment Emergent Adverse Events
Time frame: Through study completion, an average of 22 days
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 28 May 2026.
- 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.
Joel Raskin, MD study director
Sirtsei Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SP-624 in people with Major Depressive Disorder and Depression, run by Sirtsei Pharmaceuticals, Inc. at 2 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 3 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 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Brain Network Analytics Profile (time frame: At the Day 15 Visit, after approximately 2 weeks of daily dosing with the assigned study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.