JOURNAL TRANSCRIPT
sRMP DK/H/2440/001-004/DC aripiprazole
VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology
Schizophrenia is a mental disorder affecting about 7 per thousand of the adult population, mostly in the age group 15-35 years. Though the incidence (how frequently an event occurs in a population over a period of time) is low (3-10,000), the prevalence (the number of cases in a given population) is high due to chronicity. It may cause delusions, paranoia, hallucinations, disordered thinking and behavior, and catatonia. The symptoms usually begin between the ages of 16-30. People with schizophrenia -- the most chronic and disabling of the major mental illnesses -- often have problems functioning in society, at work, at school, and in relationships. Schizophrenia can leave its sufferer frightened and withdrawn. It is a life-long disease that cannot be cured but usually can be controlled with proper treatment. It is characterized by disassociated thought process and disintegration of emotional responses. Schizophrenics may experience symptoms like hallucinations, paranoia, delusions, or disorganized speech and thinking. The exact cause of schizophrenia is not yet known. Researchers have uncovered a number of factors that appear to play a role in the development of schizophrenia, including genetics, brain chemistry, brain abnormality and environmental factors. Bipolar disorder, formerly called manic depression, is a mental illness that brings severe high and low moods and changes in sleep, energy, thinking, and behavior. People who have bipolar disorder can have periods in which they feel overly happy and energized (mania) and other periods of feeling very sad, hopeless, and sluggish (depression). In between those periods, they usually feel normal. Bipolar disorder can also cause changes in energy and behavior. Bipolar disorder is not the same as the normal ups and downs everyone goes through. Bipolar symptoms are more powerful than that. They can damage relationships and make it hard to go to school or keep a job. They can also be dangerous. Some people with bipolar disorder try to hurt themselves or attempt suicide. People with bipolar disorder can get treatment. With help, they can get better and lead successful lives.
Anyone can develop bipolar disorder. The illness usually lasts a lifetime. VI.2.2 Summary of treatment benefits Aripiprazole is one of a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 years and older who suffer from a disease characterized by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behavior and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense. The recommended starting dose for aripiprazole is 10 or 15 mg/day with a maintenance dose of 15 mg/day administered on a once-aday schedule without regard to meals. Aripiprazole is effective in a dose range of 10 to 30 mg/day. Enhanced efficacy at doses higher than a daily dose of 15 mg has not been demonstrated although individual patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg. Aripiprazole is further used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less
sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In adults it also prevents this condition from returning in patients who have responded to the treatment with aripiprazole. The recommended starting dose for aripiprazole is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy. Some patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg.
VI.2.3 Unknowns relating to treatment benefits Aripiprazole is not recommended for use in patients with schizophrenia below 15 years of age due to insufficient data on safety and efficacy. Younger patients (