Clinical trial NCT05212116: A Study of SDI-118 in Participants in Remission From Depression
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Depression in Remission
Keywords: Depression
Major Depressive Disorder
Depression in Remission
Lead sponsor: Syndesi Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: P1vital Limited
First posted: 2022-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind Primary Purpose: Treatment
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: 17 days
measure: Number of participants with laboratory value abnormalities and/or adverse events (AEs)
timeFrame: 17 days
measure: Number of participants with vital sign abnormalities and/or adverse events (AEs)
timeFrame: 17 days
measure: Number of participants with routine 12 lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
timeFrame: 17 days
measure: Number of participants with C-SSRS abnormalities and/or Adverse Events (AEs)
timeFrame: 17 days
measure: Number of participants with routine physical examination abnormalities and/or Adverse Events (AEs)
timeFrame: 17 days
measure: Number of participants with Changes in the Cogstate Brief Battery, including abnormalities and/or Adverse Events (AEs)
timeFrame: 17 days
measure: Number of participants with Changes in the Digital Symbol Substitution Test, including abnormalities and/or Adverse Events (AEs)
timeFrame: 17 days
measure: Number of participants with Changes in the Controlled Oral Word Association Test, including abnormalities and/or Adverse Events (AEs)
timeFrame: 17 days
measure: Number of participants with Changes in the Category Fluency Test, including abnormalities and/or Adverse Events (AEs)
timeFrame: 17 days
Secondary outcomes:
measure: Changes in Blood Oxygen Level Dependent (BOLD) signal
timeFrame: 17 days
measure: Changes in Blood Oxygen Level Dependent (BOLD) signal
timeFrame: 17 days
measure: Performance measures associated with executive function (working memory) during the N-Back Tasks
timeFrame: 17 days
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester
state: Lancashire
city: Oxford
country: United Kingdom
facility: University of Oxford
state: Oxfordshire
city: Cardiff
country: United Kingdom
facility: Cardiff University
state: Wales
Study officials:
affiliation: University of Oxford
name: Katharine Smith, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Syndesi Therapeutics
name: Maeve Duffy, PhD
role: STUDY_CHAIR
References: