Cariprazine (Reagila) for the treatment of schizophrenia

Introduction

Cariprazine (trade name: Reagila) has been approved in Germany since July 2017 for the treatment of schizophrenia in adults.

Schizophrenia is a mental illness that changes the way a person thinks and feels, and affects how they perceive and assess reality. Schizophrenia can also affect social interaction, motivation, and the ability to cope with everyday life. Doctors group the symptoms into positive symptoms and negative symptoms.

Agitated behavior or delusional perception are considered “positive” symptoms. These include:

  • Delusions
  • Hallucinations
  • Thought disorders and feeling like your thoughts are being controlled from the outside
  • Behavioral disorders (restlessness, agitation)

Diminished behaviors are considered “negative” symptoms. These include:

  • Reduced speaking
  • Lack of emotion and inability to feel joy
  • Lack of motivation
  • Inability to establish social interaction and loss of interest in relationships with other people
  • Attention disorders

Some people experience these symptoms only once or a few times. One acute episode can last several weeks or months. Other people are constantly affected by their symptoms and need a lot of support.

Cariprazine changes the way the chemical messengers dopamine and serotonin affect the brain in order to improve the symptoms.

Application

Cariprazine is available in capsule form at dosages of 1.5 mg to 6 mg. The recommended starting dose is 1.5 mg a day. The dose can be increased slowly in 1.5 mg steps as needed, but it shouldn’t exceed 6 mg per day.

Other treatments

Standard treatments for schizophrenia include a number of different antipsychotic drugs, such as amisulpride, aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, and ziprasidone.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of cariprazine for people with schizophrenia compared with the standard treatments.

The manufacturer provided one study involving 461 people. Half of them received cariprazine, the other half received risperidone. Only people who used the medication as long-term treatment to prevent a relapse were included in the study. Also, all of the patients involved in the study had mainly negative symptoms.

This is what was found:

What are the advantages of cariprazine?

  • Psychosocial functioning: The patients were asked to self-assess their psychosocial functioning. This includes such aspects as social activities, work, studies, as well as disorderly and aggressive behavior. Here the study suggests that cariprazine has an advantage compared with risperidone.

What are the disadvantages of cariprazine?

  • Cariprazine wasn’t found to have any disadvantages compared to risperidone.

No difference

  • There were no differences in terms of severe side effects. About 3 to 4 out of 100 people in each group had severe side effects.
  • Symptoms of schizophrenia: Overall, there was also no difference between the treatments in terms of delusions, listlessness, anxiety or thought and speech disorders.
  • There were also no differences in the following areas:
    • Symptoms of
    • Treatment stopped due to side effects
    • Suicidal thoughts or behavior
    • Movement disorders
    • Slow movements or shaking (tremor)

What remains unanswered?

The manufacturer did not provide any suitable data on the following:

  • Relapses
  • Agitated movements
  • Health-related quality of life

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and the hearings received, the G-BA passed a resolution on the added benefit of cariprazine (Reagila).

Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). Cariprazin (Schizophrenie) – Nutzenbewertung gemäß § 35a SGB V. Dossierbewertung; Auftrag A18-25. 12.07.2018. (IQWiG-Berichte; Band 646).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on August 9, 2018
Next planned update: 2021

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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