Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia : A Randomized Clinical Trial.
This 12-month open-label randomized controlled trial found that long-acting injectable risperidone, compared with oral risperidone, was associated with significantly greater relapse prevention and medication adherence in patients with recent-onset schizophrenia.
- Open-label randomized controlled trial, with a fully crossed 2 x 2 design (2 drug treatments crossed with 2 psychosocial treatments). Participants and symptom raters were not blinded to treatment condition.
- N=83 patients with recent-onset schizophrenia (past 2 years) randomized to receive 12 months of either long-acting injectable risperidone or oral risperidone. Half of each treatment group received cognitive remediation (CR), while the other half received healthy-behaviors training (HBT):
- Long-acting injectable risperidone & CR (n=19)
- Long-acting injectable risperidone & HBT (n=21)
- Oral risperidone & CR (n=22)
- Oral risperidone & HBT (n=21)
- Setting: UCLA research clinic, from 2005-2012.
- Participants were 78% male, mean age 21.5 years old, mean time since psychosis onset 7 months.
- Primary outcome: psychotic exacerbation/relapse, assessed every 2 weeks with the Brief Psychiatric Rating Scale (BPRS).
- Secondary outcomes:
- Psychiatric hospitalizations.
- Psychotic symptom control, as measured by BPRS hallucinations and unusual thought content rated <4.
- Drug discontinuation.
- The long-acting injectable group had a significantly lower rate of exacerbation/relapse compared with the oral risperidone group (P<0.001):
- 5% of long-acting injectable risperidone patients relapsed (2/40 patients).
- 33% of oral risperidone patients relapsed (14/43 patients).
- There was no significant difference in exacerbation/relapse rate between the two psychosocial treatments (P=0.60):
- 22% of cognitive remediation group.
- 17% of healthy-behaviors training group.
- Of the 14 patients who relapsed while on oral risperidone, 12 occurred within the first 6 months of treatment.
- Psychiatric hospitalization was required by fewer patients receiving long-acting injectable compared with oral risperidone (5% vs 18.6%, P=0.05)
- Discontinuation of treatment owing to lack of efficacy was significantly lower for long-acting injectable compared with oral risperidone (2.5% vs 17%, P=0.01).
- Discontinuation of treatment owing to intolerable adverse effects did not differ significantly between long-acting injectable and oral risperidone (10% vs 21%, P=0.14).
- Medication adherence was significantly higher with long-acting injectable compared with oral risperidone, despite monitoring with frequent pill counts, blood tests, and the Medication Event Monitoring System.
Subotnik KL, Casaus LR, Ventura J, et al. Long-Acting Injectable Risperidone for Relapse Prevention and Control of Breakthrough Symptoms After a Recent First Episode of Schizophrenia : A Randomized Clinical Trial. JAMA Psychiatry. June 2015. doi:10.1001/jamapsychiatry.2015.0270.