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Study in Major Depressive Disorder With BTRX-335140 vs Placebo

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ClinicalTrials.gov Identifier: NCT04221230
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
BlackThorn Therapeutics, Inc.

Study Description
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Brief Summary:
A proof of concept (POC) study evaluating the impact of BTRX-335140 relative to placebo on symptoms of major depressive disorder (MDD) in adult subjects with MDD and symptoms of anhedonia and anxiety following 8 weeks of double-blind treatment as assessed by the HAMD-17 Scale.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: BTRX-335140 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Proof of Concept Study to Evaluate the Effects of Oral BTRX-335140 Versus Placebo in Subjects With Major Depressive Disorder
Actual Study Start Date : December 14, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BTRX-335140 Drug: BTRX-335140
active drug
Placebo Comparator: Placebo Drug: Placebo
placebo


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: 8 weeks ]
    Change in baseline to Week 8 on the HAMD-17 score; Minimum 0, Maximum 52; Higher scores mean a worse outcome


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are adult men or women 25 to 65 years of age (inclusive) at informed consent, who provide informed consent by signing the appropriate ICFs
  • Have a primary DSM-5 diagnosis of MDD, with prominent symptoms of anhedonia confirmed by Structured Clinical Interview for DSM Disorders, Clinical Trials Version (SCID-CT)
  • Meet the algorithm-based clinical scale criteria
  • Body mass index between 18 to 35 kg/m2
  • Medically stable (in the opinion of the investigator and Sponsor/Sponsors delegate) based on medical history, vital signs, clinical laboratory tests, and 12-lead ECG performed at screening and baseline
  • Agree to birth control
  • Willing and able to give written informed consent to participate
  • Able to understand and comply with instructions in English
  • Are judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures, including venipuncture, and examinations required by the protocol

Exclusion Criteria:

  • Any current DSM-5 disorder other than MDD (including bipolar 1 & 2, schizophrenia, personality disorder, attention deficit disorder/ attention deficit hyperactivity disorder [ADD/ADHD], bulimia nervosa, or PTSD). Subjects with comorbid GAD, social anxiety disorder (SAD) or panic disorder for whom MDD is considered the primary diagnosis are not excluded.
  • Are actively suicidal (eg, any suicide attempts within the past 12 months or any current suicidal intent, including a plan) or are at serious suicidal risk, as assessed by the C-SSRS (score of "YES" on suicidal ideations item 4 or 5 or any suicide attempt item within 3 months prior to
  • Have any significant history of substance or alcohol use disorder (lifetime) per DSM-5 criteria
  • Have signs of Cushing's disease, Addison's Disease, primary amenorrhea or other evidence of significant disorders of the hypothalamus-pituitary-adrenal (HPA) axis
  • Have any other clinically significant medical or psychiatric condition or circumstance prior to randomization that, in the opinion of the investigator, or Sponsor could affect subject safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study
  • Have had prior seizures (other than remote history of childhood febrile seizure) or other condition that would place the subject at increased
  • Have a history of serious head injury (eg, skull fracture, cerebral contusion, or trauma resulting in prolonged unconsciousness), intracranial neoplasm, or hemorrhage
  • Have had electroconvulsive treatment, transcranial magnetic stimulation or vagal nerve stimulation or treatment with ketamine or esketamine for MDD
  • Have initiated psychotherapy (such as Cognitive Behavioral Therapy) or have had a change in psychotherapy, or other non-drug therapies (such as acupuncture or hypnosis)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04221230


Contacts
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Contact: Michael Gibbons 415-548-5471 michael.gibbons@BlackThornrx.com

Locations
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United States, California
ProScience Research Group Recruiting
Culver City, California, United States, 90230
Contact: Marina Bussel         
Collaborative Neuroscience Network Recruiting
Garden Grove, California, United States, 92845
Contact: Haig Goenjian         
Behavioral Research Specialist, LLC Recruiting
Glendale, California, United States, 91206
Contact: Jesse Carr         
Synergy San Diego Recruiting
Lemon Grove, California, United States, 91945
Contact: Mohammed Bari         
Pacific Research Partners, LLC Recruiting
Oakland, California, United States, 94607
Contact: Corinna Gamez         
United States, Florida
Clinical Neuroscience Solutions, Inc. Recruiting
Jacksonville, Florida, United States, 32256
Contact: John Mark Joyce         
Clinical Neuroscience Solutions, Inc. Recruiting
Orlando, Florida, United States, 32801
Contact: Felipe Suplicy         
United States, Georgia
Atlanta Center for Medical Research Recruiting
Atlanta, Georgia, United States, 30331
Contact: Mark Lerman         
United States, Illinois
Uptown Research Institute Recruiting
Chicago, Illinois, United States, 60640
Contact: John Sonnenberg         
United States, Nevada
Altea Research Institute Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Jelena Kunovac         
Altea Research Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Jelena Kunovac         
United States, New Mexico
Albuquerque Neuroscience, Inc. Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Glen Michael Dempsey         
United States, New York
Finger Lakes Clinical Research Recruiting
Rochester, New York, United States, 14618
Contact: Sarah Atkinson         
Richmond Behavioral Associates Recruiting
Staten Island, New York, United States, 10312
Contact: Mark DiBuono         
United States, Ohio
Midwest Clinical Research Center Not yet recruiting
Dayton, Ohio, United States, 45417
Contact: Otto Dueno         
United States, Tennessee
Clinical Neuroscience Solutions, Inc. Recruiting
Memphis, Tennessee, United States, 38119
Contact: Valerie Arnold         
United States, Texas
Grayline Research Center Recruiting
Wichita Falls, Texas, United States, 76309
Contact: Benny Barnhart         
Sponsors and Collaborators
BlackThorn Therapeutics, Inc.
Investigators
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Study Director: Jane Tiller, MBChB BlackThorn Therapeutics
More Information
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Responsible Party: BlackThorn Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04221230    
Other Study ID Numbers: K2-MDD-201
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms