BridgeMD
Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
EU CTIS ID: 2024-520333-68-00
What this study is testing
To evaluate the efficacy of milsaperidone as an adjunctive treatment to antidepressant therapy for patients with Major Depressive Disorder (MDD) as measured by change from baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Meets DSM-5-TR criteria for MDD as confirmed by the Investigator and/or Sponsor-approved interviewer/rater via both: the Structural Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT), updated for DSM-5-TR, and review of the patient’s medical records/history (a phone call with the patient’s physician may be acceptable in lieu of medical records), or, if lacking adequate records, written approval from the Sponsor or Sponsor’s Designee;
- The start of the current major depressive episode (MDE) is at least 8 weeks but no more than 24 months prior to screening;
- Rater-administered MADRS total score ≥ 24 at Screening and at Baseline;
- CGI-S – Severity of Illness score of ≥ 4 at Screening and Baseline;
- Quick Inventory of Depressive Symptomatology-Self Report-16 item (QIDS-SR-16) score ≥ 14 at Screening and at Baseline;
- Currently having an inadequate response to antidepressant therapy (less than 50% improvement), as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ) and taking at least the minimum effective dose (per package insert) of one of the following antidepressants as monotherapy treatment for at least 6 weeks duration prior to the Screening Visit: bupropion, citalopram, duloxetine, escitalopram, fluoxetine, levomilnacipran (if locally approved for MDD), milnacipran (if locally approved for MDD), paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, vortioxetine
You likely can't join if
- Within the patient's lifetime, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD, including: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder; Bipolar Disorder;
- Diagnosis of any current (within 6 months) psychiatric diagnosis other than MDD that has been confirmed by DSM-5-TR including: Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment; Patients with history of GAD documented on their MR may be included if the Investigator provides sufficient evidence that the diagnosis is no longer applicable. Eating disorder; Personality disorder of sufficient severity to have a major impact on the patient's psychiatric status;
- Experiences a ≥ 25% decrease in the MADRS total score between Screening and Baseline;
- Experiences a ≥ 25% decrease in the QIDS-SR-16 total score between Screening and Baseline;
- In the opinion of the Investigator, has a significant risk for suicidal behavior during participation in the study or is considered to be in imminent danger to themselves or others. Any of the following categorically exclude a patient from participation: at Screening, the patient scores "yes" on Suicidal Ideation Items 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening, or at Baseline, the patient scores "yes" on Suicidal Ideation Items 4 or 5 since the Screening Visit; at Screening, the patient has had 1 or more suicide attempts within 2 years prior to Screening; or at Screening or Baseline, the patient scores ≥ 5 on MADRS Item 10 (Suicidal Thoughts).
- Has a first MDE at age 60 years or older.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.