Depressive Disorder, Treatment-Resistant, Major Depressive Disorder (MDD)
Conditions
Keywords
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant, Antidepressive Agents, Randomized Controlled Trial, Double-Blind Method, Clinical Trial, Phase II, Psychiatric Status Rating Scales, Ketamine
Brief summary
The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD). The main questions the study aims to answer are: * Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression? * What adverse events do participants have when taking ACP-211?
Interventions
DRUGACP-211
ACP-211 monotherapy
DRUGPlacebo
Placebo control
Sponsors
ACADIA Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults ≥18 and ≤65 years of age * Provides written informed consent * Clinical diagnosis of MDD * History of inadequate response to at least two antidepressants, with at least one inadequate response documented during the current episode * Currently treated with an approved antidepressant at a stable dose prior to Screening * MADRS total score ≥28, CGI-S score ≥4 , and QIDS-SR16 score ≥16 at Screening and Baseline * Females of childbearing potential must have a negative pregnancy test and agree to use acceptable contraception; males must agree to use barrier protection and refrain from sperm donation
Exclusion criteria
* Current diagnosis of certain personality disorders or persistent depressive disorder * Recent substance use disorders, excluding caffeine or nicotine * Active suicidal risk or recent suicidal attempt * History of schizophrenia, psychotic disorders, bipolar disorder, or MDD with psychotic features * Current treatment requirement for PTSD, acute stress disorder, panic disorder, or OCD * History of neuroleptic malignant syndrome, serotonin syndrome, or epilepsy (except single febrile seizure in infancy) * Allergy or sensitivity to ketamine or esketamine * Significant cardiovascular disease * Positive history of hepatitis B, hepatitis C, or HIV infection * Unstable diabetes or uncontrolled medical conditions * Positive urine drug test for an illicit drug or cannabis * Received neuromodulation therapies (ECT, TMS, VNS, DBS) in the current depressive episode * Recent initiation or change in psychotherapy Additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28 | Baseline and Day 28 | The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in MADRS Total Score at Day 2 | Baseline and Day 2 (24 hours postdose) | The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity. |
| Change From Baseline in MADRS Total Score at Scheduled Postbaseline Visits | Baseline through Day 28 | — |
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Scheduled Postbaseline Visits | Baseline through Day 28 | The CGI-S is a clinician-rated assessment of illness severity scored on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater illness severity. |
| Proportion of Subjects in Remission at Scheduled Postbaseline Visits (MADRS ≤10) | Up to Day 28 | — |
| Proportion of Subjects With Response at Scheduled Postbaseline Visits (≥50% Reduction From Baseline in MADRS Total Score) | Up to Day 28 | — |
| Proportion of Subjects With Sustained Response From Day 2 Through Day 28 | Day 2 through Day 28 | Subjects achieving sustained response, defined as a ≥50% reduction from Baseline in MADRS total score, with onset by Day 2 and maintained through the end of the double-blind treatment period. |
| Proportion of Subjects With Clinical Global Impression of Improvement (CGI-I) Score of 1 or 2 at Scheduled Postbaseline Visits | Up to Day 28 | The CGI-I is a clinician-rated assessment of change in illness relative to Baseline. Scores range from 1 (very much improved) to 7 (very much worse). This outcome evaluates subjects with a score of 1 (very much improved) or 2 (much improved). |
Countries
United States
Contacts
CONTACTSandy Filosi
CONTACTLori Lykens
Outcome results
None listed