ANC-501 in the Treatment of Adults With Major Depressive Disorder
- Registration Number
- NCT05439603
- Lead Sponsor
- Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.
- Brief Summary
A Phase 2 Study of ANC-501 in the treatment of adults with Major Depressive Disorder
- Detailed Description
This is a single-arm, open-label Phase 2 study to assess the safety, tolerability, pharmacokinetics (PK), and activity of ANC-501 oral capsules as adjunctive treatment in subjects diagnosed with major depressive disorder (MDD)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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], bupropion or trazodone monotherapy) for the current episode for at least 6 weeks of continuous treatment, which can include some or all of the screening period, with 4 weeks on a stable dose prior to day 1 and has an inadequate response (<50% improvement) using the MGH ATRQ.
- MADRS total score of ≥26 at screening and Day 1 (prior to dosing).
- 12-hour urine cortisol level >22.7 nmol/L(greater than or equal to 8.3 mcg/L).
- 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 psychiatric or neurologic conditions that have not been taken at a stable dose for at least 4 weeks prior to day 1.
- Significant findings on ophthalmic examination including, Best Corrected Visual Acuity (BCVA) worse than 20/30 or, in the opinion of the ophthalmologist or optometrist, any cataract that may become clinically significant and/or need surgical intervention during the course of the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ANC-501 ANC-501 50 mg/day
- Primary Outcome Measures
Name Time Method Mean Change From Baseline (Day 1) to Day 56 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. Baseline (Day 1) to Day 56 The MADRS was utilized as the primary efficacy assessment of the participant's level of depression. The MADRS consists of 10 items, all rated on a scale 0 to 6 with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. Total MADRS score range is 0 to 60. A higher score indicates more severe depression.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints. Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70 The MADRS was utilized to assess the participant's level of depression. The MADRS consists of 10 items, all rated on a scale 0 to 6 with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. Total MADRS score range is 0 to 60. A higher score indicates more severe depression.
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Response. Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70 MADRS responder rate was defined as \>=50% reduction in total score from Baseline (Day 1) to all time points. The MADRS consists of 10 questions, each rated on a 7-point scale, to stratify severity of depressive episodes. The MADRS total score is the sum of ratings for all 10 items. Total MADRS score range is 0 to 60. A higher score indicates more severe depression.
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Remission. Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70 MADRS remission rate was defined where total score was \<=10 at all time points. The MADRS consists of 10 questions, each rated on a 7-point scale, to stratify severity of depressive episodes. The MADRS total score is the sum of ratings for all 10 items. Total MADRS score range is 0 to 60. A higher score indicates more severe depression.
Mean Change From Baseline (Day 1) to Day 56 in Hamilton Anxiety Scale (HAM-A) Total Score. Baseline (Day 1) to Day 56 The HAM-A was utilized as an assessment to rate participants level of anxiety. HAM-A is a 14-item questionnaire with each question rated on a 5-point scale with a total score of 0 to 56. The higher scores indicating more severe anxiety symptoms.
Mean Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline (Day1) to Day 56. Baseline (Day1) to Day 56 The CGI-S was utilized as an assessment for clinician to rate the severity of the patient's illness at the time of the assessment, relative to past experience with patients having the same diagnosis. CGI-S is a 7-point scale with response choices included: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The response at Day 56 was compared with the participants condition at Baseline prior to the first dose of study medication.
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70 The CGI-I was utilized as an assessment for clinician to rate the improvement of the patient's illness at the time of the assessment compared to patient's condition at admission of the trial. To perform this assessment, the study physician answered the following question: "Compared to his/her condition at admission to the project, how much has he/she changed?" This question is rated on a scale from 0 to 7, where a higher score indicates greater lack of improvement. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given visit was compared with the participants condition at Baseline prior to the first dose of study medication. A CGI-I improver was defined as a subject with a CGI-I score of "Very much approved" or "Much Approved".
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement Baseline (Day1) to Day 56 The CGI-I was utilized as an assessment for clinician to rate the improvement of the patient's illness at the time of the assessment compared to patient's condition at admission of the trial. To perform this assessment, the study physician answered the following question: "Compared to his/her condition at admission to the project, how much has he/she changed?" This question is rated on a scale from 0 to 7, where a higher score indicates greater lack of improvement. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a Day 56 was compared with the participants condition at Baseline prior to the first dose of study medication. A CGI-I improver was defined as a subject with a CGI-I score of "Very much approved" or "Much Approved".
Trial Locations
- Locations (8)
Combined Research Orlando
🇺🇸Orlando, Florida, United States
Clinilabs Drug development Corporation
🇺🇸New York, New York, United States
ATP Clinical Research
🇺🇸Orange, California, United States
Florida Behavioral Medicine
🇺🇸Largo, Florida, United States
Innovative Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
Clinilabs Drug Development Corporation
🇺🇸Eatontown, New Jersey, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Conrad Clinical Research
🇺🇸Edmond, Oklahoma, United States