Cariprazine safely, effectively treats negative schizophrenia symptoms

Negative symptoms of schizophrenia — withdrawal, lack of emotion and apathy — may be treatable with cariprazine, according to results from a phase 3 clinical trial presented at the European College of Neuropsychopharmacology Congress annual meeting.

“Cariprazine, a dopamine D3/D2 receptor partial agonist with preference for D3 receptors, has demonstrated efficacy for the treatment of schizophrenia, including in three 6-week, randomized, double-blind, placebo-controlled, phase 2/3 clinical trials in patients with acute psychotic exacerbations and in one relapse prevention clinical trial in stabilized patients. Post hoc analysis of the 6-week efficacy trials on a subset of patients with high levels of negative symptoms demonstrated significantly greater improvement relative to placebo,” the researchers wrote.

Researchers enrolled 461 individuals with predominant, negative symptoms of schizophrenia in a multinational, randomized, double-blind risperidone-controlled, parallel group clinical trial to evaluate the efficacy, safety and tolerability of cariprazine. After 2 weeks of cross-titration and discontinuation of previously taken antipsychotics, patients received either cariprazine with a target dose of 4.5 mg per day (n = 230) or risperidone with a target dose of 4 mg per day (n = 231) for 24 weeks. The primary efficacy measure was improvement in Positive and Negative Syndrome Scale (PANSS) for negative symptoms from baseline to endpoint.

Study participants in both treatment groups had similar scores on the Personal and Social Performance Scale and the PANSS for negative and positive symptoms at baseline.

Compared with participants who received risperidone, those who received cariprazine exhibited greater improvements from baseline in PANSS scores for negative symptoms (P = .002) and total Personal and Social Performance Scale scores (P < .001).

Rates of discontinuation due to adverse events was low, according to researchers, suggesting cariprazine was well-tolerated. The most common adverse events were insomnia (10%) and headache (10.4%) in both treatment groups.

“Treatments for the negative symptoms of schizophrenia are still urgently needed as these are critical predictors for patient's recovery and reintegration. The current results suggest that D3-dopaminergic mechanisms may play a role in both causing and treating emotional flatness, which deserve further confirmation,” Andreas Meyer-Lindenberg, MD, PhD, executive committee member of the European College of Neuropsychopharmacology Congress, said in a press release. – by Amanda Oldt

Disclosure: The study was supported by Gedeon Richter, Plc. Please see the full study for a list of all authors’ relevant financial disclosures.

Reference:

Debelle M, et al. Cariprazine in negative symptoms of schizophrenia: Post hoc analyses of a fixed-dose, placebo and active controlled trial. Presented at: European College of Neuropsychopharmacology Congress; Aug. 29-Sept. 1, 2015; Amsterdam.