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CLE-100 as an Oral Therapy in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04103892
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Clexio Biosciences Ltd.

Tracking Information
First Submitted Date  ICMJE September 9, 2019
First Posted Date  ICMJE September 26, 2019
Last Update Posted Date September 26, 2019
Actual Study Start Date  ICMJE September 5, 2019
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
  • Frequency of adverse events [ Time Frame: 14 days ]
  • Self-Administered Karolinska Sleepiness Scale [ Time Frame: 7 days ]
    The Karolinska Sleepiness Scale is a single-item, subjective, self-reported instrument measuring sleepiness on a 9-point Likert scale (1 to 9), where a higher value represents a worse outcome.
  • Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) [ Time Frame: 7 days ]
    The MOAA/S will be used to measure treatment-emergent sedation. The MOAA/S is a widely used clinician-administered measure of alertness/sedation for clinical trials. The MOAA/S measures the alertness/sedation spectrum on a 6-point scale (0 to 5) based on verbal cues, where a higher value represents a better outcome.
  • Clinician-Administered Dissociative Symptoms Scale (CADSS) [ Time Frame: 7 days ]
    The CADSS will be administered to assess treatment-emergent dissociative symptoms. The CADSS is a 23-item instrument that is clinician-administered. Each item is scored on a 5-point scale (0 to 4. A higher value represents a worse outcome. The CADSS total score ranges between 0 and 92.
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 7 days ]
    The C-SSRS will be performed to assess suicidal ideation and behavior. The C-SSRS is an instrument used to assess suicide risk by measuring symptoms of suicidal ideation, self-harm, and suicidal behavior that is administered by trained personnel. The suicidal ideation is evaluated with a "yes/no" questionnaire and the suicidal behavior severity is scored on a 6-point scale (0 to 5) where a higher value represents a more severe behavior.
  • Four-items positive subscale from the Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 7 days ]
    Four items of the BPRS will be administered to assess treatment-emergent psychotic symptoms. The BPRS is a widely used, clinician-administered instrument that involves 4 subscales: Negative Symptoms, Positive Symptoms, Manic-Hostility, and Anxiety/Depression. The 4-item Positive Symptoms subscale of the BPRS will be used to screen for potential psychiatric symptoms (suspiciousness, hallucinations, unusual thought content, and conceptual disorganization). Each item is scored on a 7-point scale (1 to 7). where a higher value represents a worse outcome. The 4 items BPRS total score ranges between 4 and 28.
  • 20-item Physician Withdrawal Checklist (PWC-20) [ Time Frame: 14 days ]
    The PWC-20 is a clinician-administered assessment to evaluate potential withdrawal symptoms following cessation of the double-blind treatment. The PWC-20 is a shortened version of the original 35-item instrument used to determine withdraw symptoms in subjects following discontinuation of anxiolytics. The items are evaluated on a 4-point scale (0 to 3) where a higher value represents a worse outcome. The total score ranges between 0 to 60.
  • Cognitive function evaluated by Cogstate battery [ Time Frame: 7 days ]
    The Cogstate battery of cognitive tests will be used to measure psychomotor function, attention, visual learning, and working memory. The Cogstate battery will include the following tests: Detection Test, Identification Test, One Back Test, Groton Maze Test.
  • Digit Symbol Substitution Test (DSST) [ Time Frame: 7 days ]
    The DSST is a psychometric test assessing the integrity of executive function, processing speed, attention, spatial perception, and visual scanning, which are functions required for driving, and will be performed repeatedly. The DSST is a valid and sensitive instrument to evaluate cognitive dysfunction and changes in cognitive function. The DSST is a timed test taken by the subject and scored based on both the number of correct answers and the speed at which they were determined. The score ranges between 0 to 135.
  • Pharmacokinetics of CLE-100 (Cmax) [ Time Frame: 7 days ]
    Maximum observed plasma concentration (Cmax)
  • Pharmacokinetics of CLE-100 (Tmax) [ Time Frame: 7 days ]
    Time of maximum observed plasma concentration (Tmax)
  • Pharmacokinetics of CLE-100 (AUC) [ Time Frame: 8 days ]
    Area under the concentration curve
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CLE-100 as an Oral Therapy in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study
Official Title  ICMJE A Two-Part Study of CLE-100 as an Adjunct Therapy in Subjects With Major Depressive Disorder
Brief Summary The clinical trial is a Phase 2, double-blind, randomized, placebo controlled study in Major Depressive Disorder (MDD) participants currently treated with antidepressant therapy. The objective of the study is to assess CLE-100 for the treatment of MDD in participants currently treated with standard antidepressant therapy.
Detailed Description

CLEO study is performed in two parts (part A and Part B). The sponsor is currently recruiting only for the Part A of the study.

Part A will be an inpatient study to assess the safety, tolerability, and pharmacokinetics of CLE-100 in MDD participants currently treated with an antidepressant drug. It will include a screening phase (up to 35 days), a 1 week inpatient double-blind treatment phase and an outpatient post treatment safety follow-up phase of 1 week after last study drug administration. The participants will remain on their current antidepressant therapy with no dose change during the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Adjunctive Treatment of Major Depressive Disorder
Intervention  ICMJE
  • Drug: CLE-100
    1 tablet of CLE-100 administered once daily
  • Drug: placebo
    1 tablet of placebo administered once daily
Study Arms  ICMJE
  • Experimental: CLE-100
    Part A: 1 oral tablet of CLE-100 once daily (in addition to current anti-depressant drug) for 1 week.
    Intervention: Drug: CLE-100
  • Placebo Comparator: placebo
    Part A: 1 oral tablet of Placebo once daily (in addition to current anti-depressant drug) for 1 week.
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2020
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Part A

    1. Male or female between 18 to 60 years of age
    2. Primary diagnosis of MDD, without psychotic features according to DSM-5 and supported by the Mini International Neuropsychiatric Interview (MINI)
    3. MADRS score of at least 18 at Screening
    4. Treatment with stable dose of the current antidepressant therapy for at least 4 weeks for the current major depressive episode (MDE)
    5. Body mass index (BMI) between 18 and 40 kg/m2, inclusive
    6. Is able and competent to read and sign the informed consent form (ICF).

Exclusion Criteria:

  • Part A

    1. History of substance use disorder per DSM-5 criteria, except for tobacco use disorder
    2. History or current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorders, binge eating disorder dementia, delirium, amnesia, or any other significant cognitive disorder
    3. Posttraumatic stress disorder, obsessive compulsive disorder, or any other mental disorder (including personality disorders)
    4. Has any medical condition for which an increase in blood pressure or intracranial pressure poses a serious risk
    5. Female of childbearing potential without appropriate contraceptive means, pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04103892
Other Study ID Numbers  ICMJE CLE100-MDD-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Clexio Biosciences Ltd.
Study Sponsor  ICMJE Clexio Biosciences Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Clexio Biosciences Ltd.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP