What side effects are associated with this type of intervention?

Common treatments for depression, particularly when used as adjunctive therapies, can have a range of side effects. SSRIs (Selective Serotonin Reuptake Inhibitors) often cause nausea, insomnia, sexual dysfunction, and weight gain. SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) may lead to similar side effects, including increased blood pressure. Buspirone, used to augment SSRIs, can cause dizziness, headaches, and nausea. Lamotrigine, another adjunctive option, is generally well-tolerated but can cause skin rashes and, rarely, severe skin reactions. Minocycline, an antibiotic used for its anti-inflammatory properties, may lead to dizziness, gastrointestinal upset, and photosensitivity. Patients should discuss these potential side effects with their healthcare provider to make informed decisions about their treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline, and serotonin-norepinephrine reuptake inhibitors (SNRIs) like duloxetine. For patients who do not respond adequately to these treatments, adjunctive therapies have been explored. These include the addition of other medications such as buspirone, which has been studied for its potential to enhance the efficacy of SSRIs, although results have been mixed. Cognitive-behavioral therapy (CBT) is another adjunctive treatment that has shown promise in improving outcomes when combined with pharmacotherapy.

What other types of research exist?

Promising novel alternatives to adjunctive treatment for depression in 2024 include psilocybin-assisted psychotherapy, MDMA-assisted psychotherapy, and ketamine. These therapies have shown potential in clinical trials for treatment-resistant depression. Additionally, emotion recognition training and cognitive-behavioral therapy (CBT) are valuable adjunctive treatments that can enhance the efficacy of existing antidepressant therapy.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 43 for reporting.

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 • NCT03249376

18%

Headache

Somnolence

Nauseau

Dizziness

Mania

100%

80%

60%

40%

20%

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

~1360

Do I qualify?Apply below to find out

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.