Case Study of a Drug-Naïve Female Patient Treated With Cariprazine
This is a case report describing a 52-week cariprazine treatment regimen that follows the impressive clinical improvement of a patient with an early onset of schizophrenia, who had a very long untreated psychosis and negative symptoms, which usually limit treatment options, and suggest a poor prognosis.
Case description
Patient history / Diagnosis and symptoms
The 23-year-old female patient, along with her parents, visited the Institute of Rare Diseases of the Semmelweis University. Her parents suspected that something was wrong with her for a while, but this was the first time they were seeking medical help. At that point, her condition was not yet known.
The patient was quiet and restrained, so her parents told her story instead. Initially, the patient attended a bilingual secondary school where she had done very well and was socially active with friends and peers. At 15 years of age, she started having problems associated with difficulty learning languages and memorizing, and her academic performance started to deteriorate. Her personality started to gradually change, and she became increasingly irritated and was verbally and physically hostile toward her classmates. During this time, she lived at home with her parents and did not go out with friends or participate in relationships, causing her social activity to decrease considerably. The patient once told her mother that she could hear the thoughts of others and she was probably also hearing voices. The first psychiatric interview and examination revealed severely impaired cognitive functions, such as thinking, memory, and concept formation. Along with the cognitive decline, hyporesponsiveness, amotivation, a general psychomotor slowing, hypobulia, and void perspectives were also observed.
After several differential diagnostic tests, early onset schizophrenia with predominantly negative symptoms was diagnosed. The patient’s PANSS total score was very high (150 points), and her CGI-S score fell in the “severely ill” category (6 points). The PANSS score was derived dominantly from the negative items of the scale, fulfilling the criteria for predominantly negative symptoms.
Treatment
The patient was hospitalized for 2 weeks and treatment with cariprazine was initiated at the dose of 1.5 mg/day and titrated up to 4.5 mg/day over a 2-week period: the patient received 1.5 mg/day for the first 3 days, 3 mg/day from day 4 to day 12, and from day 13 onward, 4.5 mg/day. While spending these two weeks in the hospital, the patient’s “explicit negative symptoms such as poverty of speech, psychomotor retardation, and affective non-responsiveness improved; however, delusions and hallucinatory perceptions did not fade significantly”.
Two weeks after discharge, further cognitive improvement was observed. She paid more attention to the activities of family members and was more communicative, with her pace of speech being close to normal. She no longer had thinking latencies and slowed movement responses as observed at admission, and could focus on the interview, showing an adequate reaction time when asked a question. The overall clinical improvement, including cognitive functions was maintained during the next visits, and functions in activities of daily living had also improved remarkably. Her participation in her family’s daily life started to increase, as she even took responsibility for some household duties. For the first time in years, she went to the hairdresser, which was in great contrast to her previous state of self-neglect.
The patient’s PANSS Negative Subscale Score and PANSS factor score for negative symptoms (PANSS-FSNS) score were reduced by 44.44% and 41.31%, respectively, after 16 weeks of treatment. The case study expresses that “in acutely ill patients with predominantly positive symptoms who are more likely to respond well to treatment, the 50% cut-off would be a more clinically meaningful criterion; however, since even slight improvement might represent a clinically significant effect in a patient with atypical schizophrenia, the use of 25% cut-off is justified. In this regard, the 44.44% and 41.31% improvement demonstrated on PANSS Negative Symptom subscale and PANSS-FSNS, respectively, are considered a clearly clinically relevant change”.
Over the course of treatment, improvement in both negative and positive symptoms was maintained and “at her later visits (32 and 52 weeks), PANSS total score was reduced to a level that was close to the minimum, and the decrease in negative symptom scores was considerable (PANSS-NSS=66.67% and PANS-FSNS=70.00% at both time points)”. In general, after 8 weeks, mild EPS was seen, but there were no metabolic, cardiac, or other side effects, proving that cariprazine was well tolerated.
Discussion
The authors conclude that “a single case study is obviously far from being predictive for the efficacy of a drug, however, the results seen with this case are promising. With a dose recommended for patients with negative symptoms, this patient’s clinical condition, including positive, negative, and cognitive symptoms, as well as social functioning, have improved notably, with the effect maintained for over 12 months”.
COD. 300020/R34. Submitted to AIFA on 12 October 2020.
Early-Onset Schizophrenia With Predominantly Negative Symptoms: A Case Study of a Drug-Naive Female Patient Treated With Cariprazine
“With a dose recommended for patients with negative symptoms, our patient’s clinical condition, including positive, negative, and cognitive symptoms, as well as social functioning have improved notably, with the effect maintained for over 12 months. Generally, cariprazine has been well tolerated, with mild EPS observed after 8 weeks, but no metabolic, cardiac, or other side effects.”
