ANC-501 in the Treatment of Adults With Major Depressive Disorder
|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: NCT05439603|
Recruitment Status : Recruiting
First Posted : June 30, 2022
Last Update Posted : February 13, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: ANC-501||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of ANC-501 in the Treatment of Adults With Major Depressive Disorder|
|Actual Study Start Date :||September 19, 2022|
|Estimated Primary Completion Date :||March 25, 2023|
|Estimated Study Completion Date :||March 25, 2023|
Five 10 mg capsules per day
- Mean Change from Baseline Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline (Day 1) to Day 56 ]To evaluate the effect of treatment with ANC-501 capsules on depressive symptoms in subjects with major depressive disorder (MDD)
- Treatment-emergent Adverse Events [ Time Frame: Baseline (Day 1) up to Day 112 ]Incidence and severity of adverse events, including serious adverse events and adverse events leading to study discontinuation and clinically significant changes in vital signs, physical examination endpoints, clinical safety laboratory values and ECGs
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Adult male or female between 18 and 65 years of age, inclusive.
- Diagnosis of current episode of major depressive disorder (MDD) at least 8 weeks prior to screening, confirmed by Structured Clinical Interview for DSM-5 - Clinical Trials Version (SCID-5-CT).
- Have not responded to their current antidepressant therapy or to dose adjustment/treatment changes following a loss of response to their current antidepressant therapy.
- Receiving a stable dose of the same antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI] monotherapy) for the current episode for at least 8 weeks of continuous treatment with 4 weeks being on a stable dose prior to Day 1 and has an inadequate response (<50% improvement) using the MGH ATRQ.
- MADRS total score of ≥28 at screening and Day 1 (prior to dosing).
- Elevation of cortisol as measured by 12-hour urine collection.
- Inadequate response to >2 prior ADTs (not including current antidepressant) of at least 6 weeks duration each for the episode current at screening.
- Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- Administration of drugs to treat a psychiatric or neurologic condition that have been initiated within 8 weeks prior to screening and/or are not being taken at a stable dose (current dose must be stable for 4 weeks preceding screening).
- Significant findings on ophthalmic examination including, Best Corrected Visual Acuity (BCVA) worse than 20/30 or, in the opinion of the ophthalmologist, any cataract that may become clinically significant and/or need surgical intervention during the course of the trial.
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): NCT05439603
|Contact: Phil Perera, MDfirstname.lastname@example.org|
|Contact: Lara Dennieemail@example.com|
|United States, California|
|ATP Clinical Research||Recruiting|
|Orange, California, United States, 92868|
|Contact: Gustavo Alva, MD 949-354-5353 firstname.lastname@example.org|
|Principal Investigator: Gustavo Alva, MD|
|United States, Florida|
|Florida Behavioral Medicine||Recruiting|
|Largo, Florida, United States, 33770|
|Contact: Carlos Bussey 727-510-9773 email@example.com|
|Principal Investigator: Ashok M Patel, MD|
|Innovative Clinical Research, Inc.||Recruiting|
|Lauderhill, Florida, United States, 33319|
|Contact: Kadian Watson 954-990-6326 firstname.lastname@example.org|
|Contact: Fedor Richani 954-990-6326 email@example.com|
|Principal Investigator: Rishi Kakar, MD|
|Combined Research Orlando Phase I-IV||Recruiting|
|Orlando, Florida, United States, 32807|
|Contact: Adrian Delgado 407-440-4493 Adrian@clinicaltrialsorlando.com|
|Principal Investigator: Eric Carbonell, MD|
|United States, New Jersey|
|Clinilabs Drug Development Corporation||Recruiting|
|Eatontown, New Jersey, United States, 07724|
|Contact: Amber Farwig 212-994-4567 ext 66407 firstname.lastname@example.org|
|Principal Investigator: Madgy L Shenouda, MD|
|United States, New York|
|Richmond Behavioral Associates||Recruiting|
|Staten Island, New York, United States, 10314|
|Contact: Adam D Smith, PhD 718-317-5522 ext 3 Asmith@ergclinical.com|
|Principal Investigator: Mark V DiBuono, MD|
|United States, Oklahoma|
|Conrad Clinical Research||Recruiting|
|Edmond, Oklahoma, United States, 73013|
|Contact: Vicki J Conrad, M.D. 405-341-5691 email@example.com|
|Principal Investigator: Vicki J Conrad, MD|
|Study Director:||Phil Perera, MD||Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.|
|Responsible Party:||Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.|
|Other Study ID Numbers:||
|First Posted:||June 30, 2022 Key Record Dates|
|Last Update Posted:||February 13, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Depressive Disorder, Major