Caplyta

Schizophrenia, Mood Disorders

Treatment

2 FDA approvals

20 Active Studies for Caplyta

What is Caplyta

Lumateperone

The Generic name of this drug

Treatment Summary

Lumateperone is a medication recently approved to treat schizophrenia, a mental health disorder that affects about 1% of the population. It is a second-generation antipsychotic, which means it targets specific neurotransmitters in the brain, such as dopamine, serotonin, and glutamate. It has been shown to help reduce both positive and negative symptoms of schizophrenia and is thought to be safer than other antipsychotics due to its selective targeting of dopamine receptors.

Caplyta

is the brand name

Caplyta Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Caplyta

Lumateperone

2020

4

Approved as Treatment by the FDA

Lumateperone, otherwise known as Caplyta, is approved by the FDA for 2 uses which include Depression, Bipolar and Mood Disorders .

Depression, Bipolar

Used to treat Depression, Bipolar in combination with Lithium carbonate

Mood Disorders

Used to treat Depression, Bipolar in combination with Lithium carbonate

Effectiveness

How Caplyta Affects Patients

Lumateperone (also known as ITI-007) is a medication used to treat schizophrenia. It works in a different way than other antipsychotics, targeting schizophrenia symptoms while reducing side effects. It is partly an agonist and partly an antagonist of dopamine receptors in the brain. People with moderate or severe liver problems are more likely to have higher levels of lumateperone in their bloodstream, and should therefore take half the recommended daily dosage.

How Caplyta works in the body

Lumateperone is a second generation antipsychotic drug that works in a unique way to address the pathophysiology of schizophrenia. It works by reducing the amount of dopamine released in the prefrontal and mesolimbic brain regions, which are known to be affected in people with schizophrenia. It also acts on other neurotransmitters like serotonin, glutamate, GABA, and acetylcholine, as well as dopamine (D1) receptors. Lumateperone also increases the activity of N-methyl-D-aspartate (NMDA) GluN2B receptors, which are impaired in people with schizophrenia

When to interrupt dosage

The amount of Caplyta is contingent upon the recognized condition. The quantity of dosage fluctuates as per the technique of administration listed in the table below.

Condition

Dosage

Administration

Schizophrenia

, 42.0 mg

Oral, , Capsule - Oral, Capsule

Mood Disorders

, 42.0 mg

Oral, , Capsule - Oral, Capsule

Warnings

Caplyta Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Lumateperone may interact with Pulse Frequency

There are 20 known major drug interactions with Caplyta.

Common Caplyta Drug Interactions

Drug Name

Risk Level

Description

Amisulpride

Major

Lumateperone may increase the antipsychotic activities of Amisulpride.

Azelastine

Major

Lumateperone may increase the central nervous system depressant (CNS depressant) activities of Azelastine.

Deutetrabenazine

Major

The risk or severity of adverse effects can be increased when Lumateperone is combined with Deutetrabenazine.

Ethanol

Major

Lumateperone may increase the central nervous system depressant (CNS depressant) activities of Ethanol.

Oliceridine

Major

The risk or severity of hypotension, sedation, death, somnolence, and respiratory depression can be increased when Lumateperone is combined with Oliceridine.

Caplyta Toxicity & Overdose Risk

Since lumateperone is new, there is no information available yet about what happens when someone overdoses. It is likely that symptoms will be more extreme versions of the normal side effects, such as increased drowsiness.

image of a doctor in a lab doing drug, clinical research

Caplyta Novel Uses: Which Conditions Have a Clinical Trial Featuring Caplyta?

186 active studies are currently underway to explore the potential of Caplyta in alleviating symptoms of Depressive Bipolar Disorder.

Condition

Clinical Trials

Trial Phases

Schizophrenia

98 Actively Recruiting

Phase 3, Not Applicable, Early Phase 1, Phase 4, Phase 1, Phase 2

Mood Disorders

15 Actively Recruiting

Early Phase 1, Phase 2, Phase 4, Not Applicable, Phase 1, Phase 3

Caplyta Reviews: What are patients saying about Caplyta?

5

Patient Review

11/4/2022

Caplyta for Bipolar Depression

I'm grateful to have found this treatment. I feel like it's helped me more than any other medication I've tried for my depression.

4.7

Patient Review

8/28/2022

Caplyta for Bipolar Depression

Caplyta does an excellent job of handling my intrusive thoughts. It's almost like they've hired a gang of bouncers to profile negativity and block it from getting into the conscious thought club. Warning: Mid day naps are recommended (for me at least) at the moment. Hopefully once my body adjusts to Caplyta I won't need to nap much longer and should be able to stay up through the day.

4.3

Patient Review

10/26/2022

Caplyta for Bipolar Depression

Although the headaches at the beginning are quite literally the worst, after 3 days my mood lifted. 2 weeks in I'm creating again although I'm having a hard time eating and have lost a dramatic amount of weight. So far I am pleased with this medication considering just 2 weeks ago I was suicidal. If the headaches bother you take Excedrin migraine relief at the same time for the first week or so.

4

Patient Review

9/21/2022

Caplyta for Bipolar Depression

I've been on the medication for almost a month now. I haven't experienced any negative side effects, which is great. I also feel like it's slowly but surely helping me get better.

2.3

Patient Review

7/29/2022

Caplyta for Bipolar Depression

I was doing "ok" before I started taking this medication. It worked well for about a month and a half, but then I was left in crippling depression. Sometimes it's better to be happy with "ok."

1.7

Patient Review

10/13/2022

Caplyta for Bipolar Depression

I had a really terrible experience with this medication. An hour after taking the first dose, I felt awful. My mouth was dry, my arms and face were tingling, I felt hot all over, I couldn't breathe properly, and then I got a headache. This was unlike anything else I've ever experienced with any other medication.

1

Patient Review

7/16/2022

Caplyta for Bipolar Depression

After taking this medication for the first time, I started feeling pressure behind my forehead. This increased over a few hours to the point where normal volume sounds were painful, and I was also experiencing diarrhea, nausea, and balance issues. It was an all-around terrible experience that I wouldn't want to repeat for anything.

1

Patient Review

7/28/2022

Caplyta for Bipolar Depression

I tried this once and had an awful experience that included feeling extremely thirsty, dizzy, sick to my stomach, and getting a headache. Not worth it in my opinion, especially given how expensive it is.

1

Patient Review

7/17/2022

Caplyta for Bipolar Depression

I would not recommend this drug to anyone. I was in bed for four and a half days out of the three that I took it, and experienced terrible constipation.

1

Patient Review

8/24/2022

Caplyta for Bipolar Depression

Do not recommend. I took one capsule as prescribed and it sent me to the hospital with low blood pressure, shortness of breath, dizziness, and lightheadedness. I felt drugged and tired. Also caused a headache.

1

Patient Review

8/11/2022

Caplyta for Bipolar Depression

I absolutely hated this medicine. I've tried a lot of different treatments, but this was by far the worst. I had a headache, nausea, and my skin felt like it was on fire. I couldn't even sleep because I was so restless. It was torture.

1

Patient Review

11/11/2022

Caplyta for Bipolar Depression

I cannot stress enough how awful this medication made me feel. I took one pill and woke up groggy and barely able to move 17 hours later. My whole day was ruined, and I had to miss two appointments because I slept through them! Do not bother with this stuff, it's not worth it.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about caplyta

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the serious side effects of Caplyta?

"Common side effects of antipsychotics include:

  • low blood pressure upon standing up
  • increased blood sugar levels
  • high cholesterol levels
  • seizures
  • difficulty regulating body temperature
  • neuroleptic malignant syndrome (a severe condition that may include muscle rigidity and kidney failure)
  • difficulty swallowing"

Answered by AI

What is Caplyta used for?

"A prescription medication called CAPLYTA is used to treat episodes of depression that are associated with bipolar I or bipolar II disorder. It can be taken alone or with the medicines lithium or valproate, and is effective for bipolar depression. However, it is not yet known if CAPLYTA is safe and effective to use with children."

Answered by AI

Is Caplyta a mood stabilizer?

"The medication Caplyta affects the neurotransmitters dopamine, serotonin, and glutamate in order to improve symptoms of mood, thoughts, and behaviors. It may help with symptoms of schizophrenia, which can in turn improve daily functioning."

Answered by AI

Does Caplyta help anxiety?

"A previous study in patients with generalized anxiety disorder found that a single dose of the drug showed significant anti-anxiety signals in brain imaging and behavioral studies, but without evidence of sedating patients or becoming addictive."

Answered by AI

Clinical Trials for Caplyta

Have you considered Caplyta clinical trials?

We made a collection of clinical trials featuring Caplyta, we think they might fit your search criteria.
Go to Trials
Image of Vanderbilt Psychiatric Hospital in Nashville, United States.

Repetitive Transcranial Magnetic Stimulation for Schizophrenia

18 - 65
All Sexes
Nashville, TN

The central hypothesis is this: DMN connectivity can be modulated with inhibitory cTBS when delivered on an accelerated treatment schedule. This study seeks to provide evidence that accelerated, network-targeted inhibitory stimulation of the DMN leads to both altered network activity and a concomitant behavioral change in cognitive performance in individuals with schizophrenia and schizoaffective disorder. This study will also compare the effect of inhibitory cTBS in healthy individuals, as it may also lead to both altered network activity and a behavioral change in cognitive performance in individuals without schizophrenia or schizoaffective disorder. If successful, this study will have identified a safe, effective, and broadly applicable treatment for cognitive impairment in schizophrenia that has potential for translation into many other psychiatric and neurodevelopmental disorders, such as autism.

Waitlist Available
Has No Placebo

Vanderbilt Psychiatric Hospital

Heather Ward, MD

Image of Woodland International Research Group /ID# 275747 in Little Rock, United States.

Emraclidine for Schizophrenia

18 - 65
All Sexes
Little Rock, AR

Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess adverse events, change in disease activity, and how oral emraclidine moves through the body in adult participants with schizophrenia Emraclidine is an investigational drug being developed for the treatment of schizophrenia. Participants are placed in one of two parts, Part A or Part B, where each group will receive a different treatment. Participants will receive either oral emraclidine or placebo. Approximately 258 participants will be enrolled across roughly 32 sites in the United States. Participants in Part A will be assigned to one of multiple ascending doses of emraclidine or placebo administered orally for 14 days or up to 21 days. Participants in Part B will receive Emraclidine or placebo administered orally for up to 42 days. Participants will be followed for 30 days after the last dose of the study drug. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Phase 2
Recruiting

Woodland International Research Group /ID# 275747 (+6 Sites)

ABBVIE INC.

AbbVie

Have you considered Caplyta clinical trials?

We made a collection of clinical trials featuring Caplyta, we think they might fit your search criteria.
Go to Trials

Have you considered Caplyta clinical trials?

We made a collection of clinical trials featuring Caplyta, we think they might fit your search criteria.
Go to Trials