Cariprazine for Schizophrenia

Phase-Based Estimates
2
Effectiveness
3
Safety
Joint-Stock Company Scientific Centre of Personalized Medicine, Moscow, Russian Federation
Schizophrenia
Cariprazine - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Schizophrenia

Study Summary

This study is evaluating whether cariprazine is effective and safe for treating schizophrenia in adolescents.

See full description

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Cariprazine will improve 1 primary outcome in patients with Schizophrenia. Measurement will happen over the course of Baseline to Week 6.

Baseline to Week 6
Change from baseline in PANSS total score at Week 6

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

Cariprazine (6-12 mg/Day)
Akathisia
22%
Headache
12%
Constipation
11%
Nausea
11%
Insomnia
10%
Vomiting
8%
Extrapyramidal disorder
7%
Dyspepsia
6%
Restlessness
6%
Tremor
6%
Diarrhoea
5%
Dizziness
4%
Mania
2%
Bipolar I disorder
1%
Depression
1%
Hospitalisation
0%
Aggression
0%
Endometrial cancer
0%
Bipolar disorder
0%
Pulmonary embolism
0%
This histogram enumerates side effects from a completed 2011 Phase 3 trial (NCT01058668) in the Cariprazine (6-12 mg/Day) ARM group. Side effects include: Akathisia with 22%, Headache with 12%, Constipation with 11%, Nausea with 11%, Insomnia with 10%.

Trial Design

3 Treatment Groups

Placebo
Cariprazine 4.5 mg/d
Placebo group

This trial requires 330 total participants across 3 different treatment groups

This trial involves 3 different treatments. Cariprazine is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Cariprazine 4.5 mg/d
Drug
Cariprazine capsules, oral administration, once daily.
Cariprazine 1.5 mg/d
Drug
Cariprazine capsules, oral administration, once daily.
Placebo
Drug
Matching placebo capsules, oral administration, once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cariprazine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 6
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to week 6 for reporting.

Closest Location

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
DSM-5 primary diagnosis of schizophrenia.
Schizophrenia diagnosis confirmed by the K-SADS-PL administered at screening (Visit 1) by a trained clinician.
PANSS score ≥ 70 and a score of ≥ 4 (moderate) on 2 or more of the 5 items on the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution), at screening (Visit 1) and baseline (Visit 2).
CGI-S scale score of ≥ 4 (moderately ill) at screening (Visit 1) and baseline (Visit 2).

Patient Q&A Section

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

What is schizophrenia?

Add answer

It is a pervasive mental disorder that affects 1 in 250 people. It is characterized by signs and symptoms such as delusions, hallucinations, disorganized speech and thinking, and/or disorganization of thought and behavior. Patients with schizophrenia rarely receive any form of treatment or cure during their illness.\n

Unverified Answer

What are the signs of schizophrenia?

Add answer

Signs of schizophrenia include blunted affect, reduced thought content, paranoid ideation, and negative symptomology. There is also a significant association between blunted affect and negative symptomology. Blunted affect is not correlated with positive symptomology.

Unverified Answer

Can schizophrenia be cured?

Add answer

The majority of people with schizophrenia have a good prognosis for the development of mental illness if proper treatment is received in early life. However, some people who have schizophrenia remain well, and some of these individuals can be categorized in the category of individuals who achieve some form of well-being. Despite the high rate of treatment adherence and low rate of relapse, some patients do better than others.

Unverified Answer

What causes schizophrenia?

Add answer

There is an overall poor correlation between what is reported by patients with schizophrenia and what is observed by clinicians. It may be that patients are not reporting enough or too much information, or that clinicians are not able to fully examine patients. There may be a difference between what is reported by patients with schizophrenia and those with other psychiatric disorders such as depression or schizophrenia bipolar. Patients with other psychiatric disorders may have a broader definition of what symptoms are important or they may be more comfortable talking about symptoms that others are expected to be unaware of. The exact cause of schizophrenia is unknown but there are many theories proposed. It is unlikely that any one theory is correct but there are possible reasons for schizophrenia to arise.

Unverified Answer

How many people get schizophrenia a year in the United States?

Add answer

An estimated 25.1 million US adults met the criteria for schizophrenia during a one-year period, making it the fourth-most common psychiatric disorder in the United States.

Unverified Answer

What are common treatments for schizophrenia?

Add answer

Schizophrenia is treated with various antipsychotic drugs, which are often used in addition to behavioral treatment. However, the effect of treatment depends on a number of factors including the severity of the disorder, the patient's psychosocial state, etc.

Unverified Answer

Is cariprazine typically used in combination with any other treatments?

Add answer

In a recent study, findings suggest that in addition to risperidone, other antipsychotics might also contribute to increased QTc interval duration in patients receiving cariprazine in combination with all other antipsychotics except aripiprazole.

Unverified Answer

What are the common side effects of cariprazine?

Add answer

Cariprazine is well tolerated; the most common side effects experienced during the first 2 months of treatment were dilation of blood vessels, dizziness, nausea, constipation and dizziness. More than half of patients treated with cariprazine for less than 4 weeks reported experiencing a side effect. Very rarely, it has resulted in serious but unrelated neurological side effects such as acute psychosis, hallucinations or confusion, seizures, seizure-like episodes and neuroleptic malignant syndrome, also in people without psychotic symptoms. Results from a recent clinical trial suggest that cariprazine may have some potential risks of serious, rare side effects, so careful monitoring is strongly recommended.

Unverified Answer

What is the primary cause of schizophrenia?

Add answer

It is argued that schizophrenia is multifactorial with a possible contribution of both genetic and environmental factors. This view will be further developed in a forthcoming book, 'Schizophrenia: An overview of modern ideas', by Dr. Paul McQuistion.

Unverified Answer

What is the average age someone gets schizophrenia?

Add answer

The average age of people with schizophrenia tends to be between the ages of 20 and 24. This makes it the most common mental illness experienced by people around the age of 24. However, only 25% of people diagnosed with schizophrenia are currently of a working age. Therefore, interventions are necessary for those suffering from the disease at a young age.

Unverified Answer

Have there been any new discoveries for treating schizophrenia?

Add answer

It seems that the pharmacological treatments have more or less replaced the surgery-based treatments, for those who want to live with the consequences of a lifelong illness with medication. But there is no reason to believe that the medication will be completely superior to surgery. The long term benefits of the surgery in terms of maintaining quality of life far outweigh short term advantage of medication. If doctors really hope that the treatment with medication will be superior to surgery, it's a matter of time when this hope will become a reality due to improved understanding in regard to schizophrenia.

Unverified Answer

Does schizophrenia run in families?

Add answer

Findings from a recent study show that schizophrenia runs in families. Findings from a recent study suggests to be cautious when defining the family environment as a risk factor for schizophrenia. Both the degree of family history and the family environment, in the context of the individual psychopath, impact on the severity and course of schizophrenia.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Schizophrenia by sharing your contact details with the study coordinator.