Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial
2011

Efficacy of Paliperidone Palmitate in Schizophrenia

Sample size: 312 publication Evidence: moderate

Author Information

Author(s): Larry Alphs, Cynthia A Bossie, Jennifer K Sliwa, Yi-Wen Ma, Norris Turner

Primary Institution: Ortho-McNeil Janssen Scientific Affairs, LLC

Hypothesis

Does acute treatment with paliperidone palmitate improve symptoms in severely ill schizophrenia patients?

Conclusion

Acute treatment with 234 mg of paliperidone palmitate significantly improved psychotic symptoms compared to placebo by day 4.

Supporting Evidence

  • Mean PANSS total scores improved significantly with paliperidone palmitate versus placebo at day 4 and day 8.
  • Significant PANSS improvement persisted at all subsequent time points in the 234-mg group versus placebo.
  • CGI-S and PSP scores improved significantly in the 234-mg and 156-mg groups versus placebo at end point.

Takeaway

This study shows that a shot of paliperidone palmitate can help people with severe schizophrenia feel better quickly.

Methodology

This was a post hoc analysis of a 13-week, randomized, double-blind, placebo-controlled trial.

Potential Biases

Potential bias due to the study being a post hoc analysis of a trial not specifically designed for this subgroup.

Limitations

The study was a post hoc analysis and may not generalize to all patients with schizophrenia.

Participant Demographics

Participants were adults with schizophrenia, 88.1% had marked illness and 11.9% had severe illness.

Statistical Information

P-Value

0.012

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1744-859X-10-12

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