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Lumateperone for Major Depressive Disorder
Phase 3
Waitlist Available
Research Sponsored by Intra-Cellular Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 43
Awards & highlights
Pivotal Trial
Summary
This trial is testing lumateperone, a medication that may help people with depression who haven't improved with their current treatments. Lumateperone works by balancing brain chemicals to improve mood. The study includes an initial assessment, a phase where patients receive the medication, and a period to monitor safety.
Who is the study for?
This trial is for adults aged 18-65 with Major Depressive Disorder (MDD) who haven't had enough improvement from their current antidepressant treatment. They must have been on a stable dose of certain antidepressants for at least 6 weeks and be experiencing moderate to severe depression symptoms.
What is being tested?
The study tests Lumateperone as an additional treatment alongside existing antidepressant therapy (ADT) compared to a placebo, in patients whose MDD hasn't improved sufficiently with ADT alone. It's randomized and double-blind, meaning neither the participants nor the researchers know who gets the real medicine or placebo.
What are the potential side effects?
While specific side effects of Lumateperone are not listed here, common side effects in psychiatric medications can include dizziness, sleepiness, weight changes, gastrointestinal issues like nausea or constipation, and sometimes mood swings or agitation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 43
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 43
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Montgomery-Åsberg Depression Rating Scale
Secondary study objectives
Clinical Global Impression Scale-Severity
Side effects data
From 2019 Phase 3 trial • 381 Patients • NCT0324937618%
Headache
9%
Somnolence
6%
Nauseau
5%
Dizziness
1%
Mania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lumateperone
Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lumateperone 42 mgExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumateperone
2021
Completed Phase 3
~1840
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression include pharmacotherapy and psychotherapy, often used in combination to enhance efficacy. Antidepressants, such as SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), work by increasing the levels of neurotransmitters like serotonin and norepinephrine in the brain, which helps improve mood and emotional stability.
Adjunctive treatments, such as Cognitive Behavioral Therapy (CBT) or additional medications like atypical antipsychotics, can further enhance the response by addressing different aspects of depression, such as thought patterns and additional neurotransmitter pathways. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and manage expectations regarding the efficacy and potential side effects of their therapy.
Quality of Life Impacts of Bright Light Treatment, Fluoxetine, and the Combination in Patients with Nonseasonal Major Depressive Disorder: A Randomized Clinical Trial.A model of placebo response in antidepressant clinical trials.Bulimia nervosa : a review of therapy research.
Quality of Life Impacts of Bright Light Treatment, Fluoxetine, and the Combination in Patients with Nonseasonal Major Depressive Disorder: A Randomized Clinical Trial.A model of placebo response in antidepressant clinical trials.Bulimia nervosa : a review of therapy research.
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Who is running the clinical trial?
Intra-Cellular Therapies, Inc.Lead Sponsor
40 Previous Clinical Trials
10,195 Total Patients Enrolled
8 Trials studying Depression
4,046 Patients Enrolled for Depression