What side effects are associated with this type of intervention?

Common treatments for depression, particularly when used as adjunctive therapies, can have various 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. Bupropion, another augmentative option, can cause insomnia, dry mouth, and an increased risk of seizures. Buspirone, used for anxiety and as an adjunct, may result in dizziness, headaches, and nausea. Atypical antipsychotics, sometimes added to antidepressant regimens, can cause weight gain, metabolic changes, and extrapyramidal symptoms such as tremors or restlessness. It's important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to individual needs and tolerances.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of depression, including those used as adjunctive therapies to enhance the efficacy of existing antidepressant treatments. Notable examples include aripiprazole (Abilify), which is often added to standard antidepressants when patients do not respond adequately to monotherapy. Other adjunctive treatments include quetiapine (Seroquel) and brexpiprazole (Rexulti). These medications are typically used when patients have not achieved sufficient symptom relief from initial antidepressant treatments alone.

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 recent studies for treatment-resistant depression and psychiatric distress. Additionally, second-generation antipsychotics such as aripiprazole and brexpiprazole remain viable options for augmentation.

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Lumateperone for Depression

Phase 3

Recruiting

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

Male or female patients between the ages of 18 and 65 years, inclusive;

Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;

Must not have

The patient has a first MDE at age 60 years or older.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 43

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new drug for people with depression who haven't responded to other treatments. It's a double-blind study, which means that neither the patients nor the researchers will know who's receiving the real drug or the placebo.

Who is the study for?

Adults aged 18-65 with Major Depressive Disorder (MDD) not adequately responding to current antidepressants can join. They must have moderate depression severity and been in their current depressive episode for 8 weeks to 18 months. Excluded are those with other major psychiatric disorders, significant suicide risk, or a substantial improvement in symptoms just before the trial starts.

What is being tested?

The study is testing Lumateperone as an add-on treatment compared to a placebo in patients already on antidepressant therapy. It's a multicenter trial where participants are randomly assigned to either the drug or placebo group without knowing which one they receive.

What are the potential side effects?

While specific side effects of Lumateperone aren't listed here, similar medications often cause drowsiness, dizziness, stomach upset, weight changes, and sometimes more serious side effects like mood swings or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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My depression is considered at least moderate in severity.

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My illness severity is moderate or worse, as rated by a professional.

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I am between 18 and 65 years old.

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My depression is considered at least moderate in severity.

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My illness severity is at least moderate, as rated by a professional.

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My depression score is 14 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My first major depressive episode occurred at age 60 or older.

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-Asberg 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

0 / 8Eligibility criteria met

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. Pharmacological treatments often involve antidepressants like SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), which work by increasing the levels of neurotransmitters such as serotonin and norepinephrine in the brain, thereby improving mood and emotional state. Adjunctive treatments, such as adding atypical antipsychotics or other medications like bupropion, aim to enhance the efficacy of existing antidepressant therapy by targeting different neurotransmitter systems or pathways. Psychotherapeutic approaches, such as Cognitive Behavioral Therapy (CBT), focus on changing negative thought patterns and behaviors. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, manage expectations, and adhere to their prescribed therapies, ultimately improving their chances of achieving remission.

Pharmacological approaches to the challenge of treatment-resistant depression.Ketamine: promising path or false prophecy in the development of novel therapeutics for mood disorders?Selective DNA methylation of BDNF promoter in bipolar disorder: differences among patients with BDI and BDII.