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A double-blind, placebo controlled, randomized trial of riluzole as an adjunct to risperidone for treatment of negative symptoms in patients with chronic schizophrenia

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Abstract

Rationale

Several recent studies have focused on glutamate modulating agents for symptoms relief in schizophrenia, especially negative symptoms which are resistant to conventional therapies.

Objectives

We aimed to assess the efficacy and tolerability of riluzole, an anti-glutamate agent with neuroprotective properties, as an adjunct to risperidone in improving negative symptoms of schizophrenia.

Methods

In this randomized double-blind placebo-controlled parallel-group study, 50 patients with chronic schizophrenia and a score of ≥20 on the negative subscale of positive and negative syndrome scale (PANSS) were enrolled in the active phase of their illness. Participants were equally randomized to receive riluzole (100 mg/day) or placebo in addition to risperidone (up to 6 mg/day) for 8 weeks. Participants were rated by PANSS every 2 weeks. The primary outcome of this study was the difference in the decrease of PANSS negative subscale score from baseline to the study endpoint between the two groups.

Results

By the study endpoint, riluzole-treated patients showed significantly greater improvement in the negative symptoms (P < 0.001) as well as the PANSS total and general psychopathology subscale scores (P = 0.001 and P < 0.001; respectively) compared to the placebo group. Treatment group was the only significant predictor of changes in negative symptom in this trial (β = −0.56, P < 0.001). No significant difference was observed between two groups in the frequency of side effects.

Conclusion

These preliminary findings suggest that riluzole may be a safe and effective medication for the treatment of negative symptoms in patients with chronic schizophrenia. Further research and replication of study findings is warranted.

Clinical trial registry name and registration number

Iranian registry of clinical trials www.irct.ir, IRCT201107281556N26

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Acknowledgements

This study was supported by a grant from Tehran University of Medical Sciences to Prof. Shahin Akhondzadeh (grant no. 14037). This study was Dr. Maryam Sabzabadi’s postgraduate thesis toward the Iranian Board of Psychiatry.

Conflict of interest

No conflict of interest exists for any of the authors associated with the manuscript and there was no source of extra-institutional commercial funding. The funding organization had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript and the decision to submit the paper for publication.

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Authors and Affiliations

  1. Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, 13337, Iran

    Mehdi Farokhnia, Maryam Sabzabadi, Seyed-Mohammad-Reza Hosseini, Habibeh Yekehtaz & Shahin Akhondzadeh

  2. Razi Hospital, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran

    Hossein Pourmahmoud & Mohammad-Reza Khodaie-Ardakani

  3. Department of Medical Genetics, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran

    Mina Tabrizi

  4. Department of Psychiatry, Kurdistan University of Medical Sciences, Sanandaj, Iran

    Farzin Rezaei

  5. Department of Psychiatry, Arak University of Medical Sciences, Arak, Iran

    Bahman Salehi

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  1. Mehdi Farokhnia
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  2. Maryam Sabzabadi
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  3. Hossein Pourmahmoud
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  10. Shahin Akhondzadeh
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Corresponding author

Correspondence to Shahin Akhondzadeh.

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Farokhnia, M., Sabzabadi, M., Pourmahmoud, H. et al. A double-blind, placebo controlled, randomized trial of riluzole as an adjunct to risperidone for treatment of negative symptoms in patients with chronic schizophrenia. Psychopharmacology 231, 533–542 (2014). https://doi.org/10.1007/s00213-013-3261-z

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  • DOI: https://doi.org/10.1007/s00213-013-3261-z

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