- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05212116
A Study of SDI-118 in Participants in Remission From Depression
April 14, 2022 updated by: Syndesi Therapeutics
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lancashire
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Manchester, Lancashire, United Kingdom
- University of Manchester
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom
- University of Oxford
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Wales
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Cardiff, Wales, United Kingdom
- Cardiff University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SDI-118 low dose
SDI-118 (low dose) orally once daily (QD) for 17±1 day.
|
SDI-118 is presented as low dose, and high dose capsules.
|
EXPERIMENTAL: SDI-118 high dose
SDI-118 (high dose) orally once daily (QD) for 17±1 day.
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SDI-118 is presented as low dose, and high dose capsules.
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PLACEBO_COMPARATOR: Placebo
Placebo orally once daily (QD) for 17±1 day.
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The Matching Placebo for SDI-118 is mannitol in capsules.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
17 days
|
Number of participants with C-SSRS abnormalities and/or Adverse Events (AEs)
Time Frame: 17 days
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Number of participants with potentially clinically significant changes in C-SSRS values.
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17 days
|
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.
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17 days
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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.
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17 days
|
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.
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17 days
|
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.
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17 days
|
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)
|
17 days
|
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
|
17 days
|
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
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17 days
|
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
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17 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Blood Oxygen Level Dependent (BOLD) signal
Time Frame: 17 days
|
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
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17 days
|
Changes in Blood Oxygen Level Dependent (BOLD) signal
Time Frame: 17 days
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As measured by changes in processing of emotional stimuli during theperformance of the FEP task.
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17 days
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Performance measures associated with executive function (working memory) during the N-Back Tasks
Time Frame: 17 days
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As measured by both response accuracy and response latency between cue stimulus and detection of this cue in the presented trial stimuli.
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17 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Katharine Smith, DM, University of Oxford
- Study Chair: Maeve Duffy, PhD, Syndesi Therapeutics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 16, 2021
Primary Completion (ACTUAL)
March 11, 2022
Study Completion (ACTUAL)
March 11, 2022
Study Registration Dates
First Submitted
May 26, 2021
First Submitted That Met QC Criteria
January 26, 2022
First Posted (ACTUAL)
January 27, 2022
Study Record Updates
Last Update Posted (ACTUAL)
April 22, 2022
Last Update Submitted That Met QC Criteria
April 14, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYND004
- 2020-003748-10 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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