Study in Major Depressive Disorder With BTRX-335140 vs Placebo
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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: NCT04221230 |
Recruitment Status :
Recruiting
First Posted : January 9, 2020
Last Update Posted : February 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Drug: BTRX-335140 Drug: Placebo | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: BTRX-335140 |
Drug: BTRX-335140
active drug |
Placebo Comparator: Placebo |
Drug: Placebo
placebo |
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
Contact: Michael Gibbons | 415-548-5471 | michael.gibbons@BlackThornrx.com |
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 |
Study Director: | Jane Tiller, MBChB | BlackThorn Therapeutics |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |