A Phase 2 Study of ANC-501 in the treatment of adults with Major Depressive Disorder
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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Five 10 mg capsules per day
ATP Clinical Research
Orange, California, United States
Florida Behavioral Medicine
Largo, Florida, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida, United States
Combined Research Orlando
Orlando, Florida, United States
Mean Change From Baseline (Day 1) to Day 56 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
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.
Time frame: Baseline (Day 1) to Day 56
Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints.
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.
Time frame: Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Response.
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.
Time frame: Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70
Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Remission.
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.
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Clinilabs Drug Development Corporation
Eatontown, New Jersey, United States
Clinilabs Drug development Corporation
New York, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Conrad Clinical Research
Edmond, Oklahoma, United States
Time frame: Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70
Mean Change From Baseline (Day 1) to Day 56 in Hamilton Anxiety Scale (HAM-A) Total Score.
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.
Time frame: Baseline (Day 1) to Day 56
Mean Change in Clinical Global Impression-Severity (CGI-S) Score From 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.
Time frame: Baseline (Day1) to Day 56
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement
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".
Time frame: Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70
Number of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement
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".
Time frame: Baseline (Day1) to Day 56