Long-acting Paliperidone Safe, Effective for Dual Psychosis

Daniel M. Keller, PhD

March 11, 2014

MUNICH — Switching patients with dual psychosis from other long-acting and oral antipsychotic medications to long-acting injectable paliperidone palmitate (LAIPP) (Invega Sustenna, Janssen Pharmaceuticals, Inc) is safe and effective, new research suggests.

Results of a small study presented here at the 22nd European Congress of Psychiatry (EPA) showed that patients remained clinically stable and did not show more adverse effects after switching.

Lead researcher José Maria Vázquez Vázquez, MD, a psychiatrist at the Public Health Agency of Barcelona, Spain, told conference delegates that substance use disorders, especially alcohol dependency or abuse, are common in patients with schizophrenia. Many patients depend on, or abuse, more than 1 substance.

To gauge the efficacy and tolerability of LAIPP in psychotic patients with substance abuse disorders, Dr. Vázquez Vázquez and colleagues performed an open-label, noninterventional, prospective study of 42 outpatients who received LAIPP monotherapy.

At baseline and at 3 and 6 months, they administered the Brief Psychiatric Rating Scale to assess psychotic symptoms and the Udvalg für Kliniske Undersøgelser (UKU) Scale to evaluate treatment tolerability. Complete data were available at the end of the study for 35 of the initial 42 patients.

Among the participants, the most prevalent psychotic diagnoses were unspecified psychosis (38%) and schizophrenia (36%), followed by bipolar I disorder, schizoaffective disorder, and induced psychotic disorder. Substance abuse disorders involved alcohol (31%), opiates (26%), cocaine (24%), cannabis (14%), and benzodiazepines (5%).

At baseline, 84% of the patients had a Global Assessment of Functioning Scale score of 60-80 (out of 100). Baseline treatment consisted of long-acting risperidone (71%) or oral antipsychotic agents (29%), the most common being olanzapine or quetiapine (of the oral agents, 28.6% each). Patients were also receiving antidepressants, mood stabilizers, benzodiazepines, drugs for substance abuse, or other drugs.

After 6 months of treatment with LAIPP, the group of 35 patients showed significant improvement in the categories of positive symptoms, negative symptoms, affective symptoms, and motor symptoms.

There was also significant improvement in several domains within these categories (all P < .01 except negative symptoms/disorientation [P = .013] and motor symptoms/excitement [P = .025]).

Between months 3 and 6, there was significant improvement in the positive symptoms of disorganization and suspiciousness, the negative symptom of disorientation, and motor symptoms of uncooperativeness and excitement.

Adverse effects decreased significantly on LAIPP, according to results on the UKU Scale; these effects included asthenia, sedation, failing memory, tension, insomnia, rigidity, tremor, weight gain, and sexual dysfunction. Most doses of LAIPP at baseline and at months 3 and 6 were between 75-100 mg monthly.

Table. Domains With Decreased Adverse Effects on LAIPP (UKU Scale) (N = 35)

Domain P-value
Psychic effects  
Asthenia .029
Sedation .003
Memory disorders .023
Concern .023
Insomnia .019
Neurologic effects  
Rigidity .011
Tremor .027
Other effects  
Weight gain .003
Sexual dysfunction .031

 

Dr. Vázquez Vázquez concluded that switching to LAIPP from other long-acting and oral antipsychotic treatments was safe and effective in patients with dual pathology and caused no increase in adverse effects after switching.

"We consider important our results because dual-pathology patients are regularly excluded from most of psychopharmacology clinical trials, and therefore, there is a relative lack of empirical data regarding the treatment of this difficult-to-treat but much needed of help population," he said.

Session chair Sebastien Guillaume, MD, PhD, associate professor of psychiatry at CHU Montpellier in France, commented to Medscape Medical News that "the interest of that study is on tolerability because, as he mentioned, most of the protocols that were industry funded excluded this type of patient, patients with dual disorder...so it is interesting to have data on these people, because honestly, we didn't know if it's safe, and the main interest of this study is that it's safe. It's tolerability is OK in these patients."

He suggested that the study needs be replicated.

Dr. Guillaume added that it is difficult to discuss efficacy in this trial because it was open-label and there was no information on patient selection for LAIPP treatment. So patients may have improved as well on other antipsychotic medications.

Dr. Vázquez Vázquez reports no relevant financial relationships. There was no commercial funding for the study. Dr. Guillaume was not involved in the study. He reports that he has research grants from Servier Laboratories and receives honoraria from Servier, Lundbeck, and Bristol-Myers Squibb.

22nd European Congress of Psychiatry (EPA). Session FC01. Presented March 2, 2014.

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