Depression in RemissionPhase 1NCT05212116
A Study of SDI-118 in Participants in Remission From Depression
A Phase 1 study testing SDI-118 in people with Depression in Remission, run by Syndesi Therapeutics at 3 sites in United Kingdom.
Trial summary
This is a multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on male and female study participants reporting with cogntive decline and who in remission from depression. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression in Remission
- What is being tested?
- SDI-118
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 16 Sep 2021to 11 Mar 2022
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants between 25 and 55 years of age (inclusive) at screening.
- Are remitted from depression.
- Have received prescribed treatment with an antidepressant or a recognised psychotherapy for depression (e.g. cognitive behaviour therapy) for a previous MDE
- Report present subjective cognitive impairment (such as difficulty concentrating, slow thinking, and difficulty in learning new things or remembering things).
- Have not been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to Screening Visit 1.
- Otherwise healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, haematologic assessments, and urinalysis, measurement of vital signs, and Electrocardiogram (ECG).
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- Negative serology test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at screening.
- Have a body mass index (BMI) of 18 to 36 inclusive.
- Agree not to use herbal medications (including herbal tea, St. John's Wort), within 14 days prior to study agent administration through to the final follow-up visit.
- Participants must be able and willing to give written, informed consent, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- The participant, in the opinion of the investigator, is willing and able to adhere to the study visit schedule and other requirements, prohibitions and restrictions of the study.
Who cannot join
- They are left-handed.
- Have immediate recall of greater than 22 words from the International Shopping List Test (ISLT) and have delayed recall of greater than 8 words from the ISLT 15 mins after the presentation of the word list.
- Positive urine drug screen or alcohol breath test at screening or assessment visits.
- History or presence of significant neurological or psychiatric conditions except those related to MDD.
- Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 3 months prior to screening or at screening or baseline visit.
- Has a known clinically relevant structural brain abnormality as determined by e.g. previous MRI, or, persistent MRI imaging artefact which is judged to produce extensive imaging distortions.
- Has a disease or takes medication that could, in the investigator's and/or sponsor's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Cardiff University
Cardiff, Wales
University of Manchester
Manchester, Lancashire
University of Oxford
Oxford, Oxfordshire
About this study
Official title: A Phase Ib, Exploratory, Double Blind, Placebo Controlled, Parallel Group, Study of SDI-118 to Evaluate Safety, Tolerability, and Pharmacodynamics Including Cognitive Function in Male and Female Participants in Remission From Depression
This is a multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on male and female study participants reporting with cogntive decline and who in remission from depression.
- Conditions
- Depression in Remission
- Being tested
- SDI-118, Placebo
- Keywords
- Depression, Major Depressive Disorder, Depression in Remission
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDI-118Drug
SDI-118 is presented as low dose, and high dose capsules.
PlaceboDrug
The Matching Placebo for SDI-118 is mannitol in capsules.
| Study group | Role | What they receive |
|---|---|---|
| SDI-118 low dose | Experimental | SDI-118 (low dose) orally once daily (QD) for 17±1 day. Receives: Drug: SDI-118 |
| SDI-118 high dose | Experimental | SDI-118 (high dose) orally once daily (QD) for 17±1 day. Receives: Drug: SDI-118 |
| Placebo | Placebo comparator | Placebo orally once daily (QD) for 17±1 day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
Measured: 17 days
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values (hematology/chemistry/urinalysis)
Measured: 17 days
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values
Measured: 17 days
Number of participants with routine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant ECG values
Measured: 17 days
Number of participants with C-SSRS abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in C-SSRS values.
Measured: 17 days
Number of participants with routine physical examination abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in physical examination.
Measured: 17 days
Number of participants with Changes in the Cogstate Brief Battery, including abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in the Cogstate Brief Battery values
Measured: 17 days
Number of participants with Changes in the Digital Symbol Substitution Test, including abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in the DSST values.
Measured: 17 days
Number of participants with Changes in the Controlled Oral Word Association Test, including abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in the COWAT values.
Measured: 17 days
Number of participants with Changes in the Category Fluency Test, including abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant changes in the CFT values.
Measured: 17 days
Secondary outcomes (3)
Changes in Blood Oxygen Level Dependent (BOLD) signal
As measured by changes in deoxyhemoglobin levels driven by localized changes in brain blood flow and blood oxygenation in brain networks associated with executive function (working memory), including the prefrontal cortex, the hippocampus, and the associated limbic networks, during performance of the N-Back Tasks
Measured: 17 days
Changes in Blood Oxygen Level Dependent (BOLD) signal
As measured by changes in processing of emotional stimuli during theperformance of the FEP task.
Measured: 17 days
Performance measures associated with executive function (working memory) during the N-Back Tasks
As measured by both response accuracy and response latency between cue stimulus and detection of this cue in the presented trial stimuli.
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start16 Sep 2021
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
Why it stopped: Development Plan Amended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in RemissionStudies 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
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind Primary Purpose: Treatment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syndesi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- P1vital Limited
- Responsible party
- Sponsor
- Investigators
- Katharine Smith, DM, Principal investigator, University of OxfordMaeve Duffy, PhD, Study chair, Syndesi Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212116
- Sponsor's protocol ID
- SYND004
- Other IDs
- 2020-003748-10
- Status last verified
- Apr 2022
- First submitted
- 26 May 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Exploratory, Double Blind, Placebo Controlled, Parallel Group, Study of SDI-118 to Evaluate Safety, Tolerability, and Pharmacodynamics Including Cognitive Function in Male and Female Participants in Remission From Depression
- ClinicalTrials.gov ID
- NCT05212116
- Acronym / sponsor ID
- SYND004
- Conditions
- Depression in Remission
- Keywords
- Depression, Major Depressive Disorder, Depression in Remission
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Development Plan Amended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Syndesi TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- P1vital Limited
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 27 Jan 2022 (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 multi-center, double-blind, randomized, placebo-controlled study to determine the safety, tolerability, and pharmacodynamics of SDI-118 in a once daily (QD) dosing regimen on male and female study participants reporting with cogntive decline and who in remission from depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind Primary Purpose: Treatment
| Arm | Type | Receives |
|---|---|---|
| SDI-118 low dose | Experimental | Drug: SDI-118SDI-118 (low dose) orally once daily (QD) for 17±1 day. |
| SDI-118 high dose | Experimental | Drug: SDI-118SDI-118 (high dose) orally once daily (QD) for 17±1 day. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo orally once daily (QD) for 17±1 day. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male and female participants between 25 and 55 years of age (inclusive) at screening.
- Are remitted from depression.
- Have received prescribed treatment with an antidepressant or a recognised psychotherapy for depression (e.g. cognitive behaviour therapy) for a previous MDE
- Report present subjective cognitive impairment (such as difficulty concentrating, slow thinking, and difficulty in learning new things or remembering things).
- Have not been treated with antidepressants or received other psychotherapy for depression for at least six weeks prior to Screening Visit 1.
Key exclusion criteria (7 listed)
- They are left-handed.
- Have immediate recall of greater than 22 words from the International Shopping List Test (ISLT) and have delayed recall of greater than 8 words from the ISLT 15 mins after the presentation of the word list.
- Positive urine drug screen or alcohol breath test at screening or assessment visits.
- History or presence of significant neurological or psychiatric conditions except those related to MDD.
- Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 3 months prior to screening or at screening or baseline visit.
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 |
|---|---|---|
| SDI-118SDI-118 is presented as low dose, and high dose capsules. | Drug | SDI-118 high dose, SDI-118 low dose |
| PlaceboThe Matching Placebo for SDI-118 is mannitol in capsules. | Drug | Placebo |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: 17 days
Adverse events (AEs) will be coded using medical dictionary for regulatory activities (MedDRA). An AE is any untoward medical occurrence in a participant administered a study drug and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical product whether or not considered related to the medical product. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant laboratory values (hematology/chemistry/urinalysis)
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant vital sign values
Number of participants with routine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant ECG values
Number of participants with C-SSRS abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant changes in C-SSRS values.
Number of participants with routine physical examination abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant changes in physical examination.
Number of participants with Changes in the Cogstate Brief Battery, including abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant changes in the Cogstate Brief Battery values
Number of participants with Changes in the Digital Symbol Substitution Test, including abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant changes in the DSST values.
Number of participants with Changes in the Controlled Oral Word Association Test, including abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant changes in the COWAT values.
Number of participants with Changes in the Category Fluency Test, including abnormalities and/or Adverse Events (AEs)
Time frame: 17 days
Number of participants with potentially clinically significant changes in the CFT values.
3 secondary outcomes
Changes in Blood Oxygen Level Dependent (BOLD) signal
Time frame: 17 days
Changes in Blood Oxygen Level Dependent (BOLD) signal
Time frame: 17 days
Performance measures associated with executive function (working memory) during the N-Back Tasks
Time frame: 17 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- 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.
Katharine Smith, DM principal investigator
University of Oxford
Maeve Duffy, PhD study chair
Syndesi Therapeutics
3 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 SDI-118 in people with Depression in Remission, run by Syndesi Therapeutics at 3 sites in United Kingdom.
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 11 inclusion and 7 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: withdrawn, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of participants with Adverse Events (AEs) (time frame: 17 days). The study lists 10 primary outcomes in all. 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 22 Apr 2022.