Efficacy of Spironolactone As an Adjunctive Therapy to Risperidone to Improve Symptoms of Schizophrenia; A Double-Blind, Randomized, Placebo-Controlled, Clinical Trial

Objective: Spironolactone (C24H32O4S), a potent mineralocorticoid receptor (MR) inhibitor, is a potassium-sparing diuretic that is traditionally used to treat fluid build-up in the body or for its anti-androgenic properties. This study is a double-blind, placebo-controlled, randomized clinical trial assessing the beneficial effects of spironolactone in addition to risperidone in improving negative symptoms of schizophrenia. Method: 40 patients with chronic schizophrenia, aged 18–60 years, were assigned to two groups: risperidone + spironolactone or risperidone + placebo. Risperidone was administered to both the spironolactone and placebo groups with a dose up to 6 mg/day throughout the trial. Spironolactone (C24H32O4S) was ordered 100 mg/day for the full 8-week course of the study. Patients were rated on the Positive and Negative Syndrome Scale (PANSS) at four time points: baseline, weeks two, four, and eight. The PANSS negative subscale score was the main objective. Results: PANSS negative, positive, and total scores showed significantly greater improvements in the spironolactone relative to the placebo group from baseline to the trial endpoint (P (Cohen’s d): 0.004 (0.96), 0.007 (0.90), and 0.042 (0.66), respectively). Similarly, ANOVA also presented significant time × treatment interaction effect for spironolactone on PANSS negative (F = 9.04; ηp2 = 0.19; df = 1.38; P = 0.002), positive (F = 3.43; ηp2 = 0.08; df = 2.72; P = 0.023), and total (F = 3.94; ηp2 = 0.09; df = 2.05; P = 0.022) scores. However, spironolactone did not cause significant decrease in the general psychiatric pathology score of PANSS. Conclusion: Our findings suggest the efficacy and safety of spironolactone as an adjunctive therapy to risperidone in improving the symptoms of schizophrenia.

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The treatment of negative symptoms and deficit states of chronic schizophrenia: olanzapine compared to amisulpride and placebo in a 6-month double-blind controlled clinical trial

Acta Psychiatrica Scandinavica ◽

10.1111/j.1600-0447.2006.00887.x ◽

2006 ◽

Vol 114 (5) ◽

pp. 319-327 ◽

Cited By ~ 51

Author(s):

Y. Lecrubier ◽

P. Quintin ◽

M. Bouhassira ◽

E. Perrin ◽

S. Lancrenon

Keyword(s):

Clinical Trial ◽

Negative Symptoms ◽

Chronic Schizophrenia ◽

Controlled Clinical Trial ◽

Double Blind

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Vortioxetine as adjunctive therapy to risperidone for treatment of patients with chronic schizophrenia: A randomised, double-blind, placebo-controlled clinical trial

Journal of Psychopharmacology ◽

10.1177/0269881120909416 ◽

2020 ◽

Vol 34 (5) ◽

pp. 506-513 ◽

Cited By ~ 1

Author(s):

Ehsan Moazen-Zadeh ◽

Samaneh Bayanati ◽

Kimia Ziafat ◽

Farzin Rezaei ◽

Bita Mesgarpour ◽

...

Keyword(s):

Clinical Trial ◽

Adjunctive Therapy ◽

Negative Symptoms ◽

Rating Scale ◽

Chronic Schizophrenia ◽

Mean Difference ◽

Double Blind ◽

General Psychopathology ◽

Double Blind Placebo ◽

End Point

Introduction and objectives: Vortioxetine, a novel antidepressant, may be an interesting candidate for adjunctive therapy of schizophrenia. Our primary objective was to investigate the effect of vortioxetine on negative symptoms, with the assessment of positive, general psychopathology and total symptoms as our secondary goal. Methods: This was an eight-week randomised, double-blind, placebo-controlled, parallel-group clinical trial, in which 78 inpatients with chronic schizophrenia were stabilised with risperidone (4–6 mg/day) for two months before being assigned to adjunctive vortioxetine (10 mg b.i.d.) or placebo. The patients were assessed using the Positive and Negative Syndrome Scale (PANSS), Extrapyramidal Symptom Rating Scale and Hamilton Depression Rating Scale during the study course. All participants had a PANSS negative symptoms subscale score of ⩾16 at baseline. Sixty-eight patients completed the trial. Results: Vortioxetine improved the negative symptoms score as the primary outcome and total PANSS score as a secondary outcome significantly better than placebo from baseline to end point at week 8, accompanied by significant time × treatment interactions and effect sizes (negative symptoms: mean difference (95% confidence interval (CI)) = −1.82 (−2.73 to −0.92); total scores: mean difference (95% CI) = −2.09 (−3.16 to −1.01). No significant difference was detected for changes in positive symptoms score or PANSS general psychopathology score as the other secondary outcomes from baseline to end point between the two treatment arms. The incidence of adverse events was comparable between groups. Conclusions: This is the first study to provide evidence for the therapeutic effect of vortioxetine on negative symptoms as an adjunctive to treatment with antipsychotics in patients with schizophrenia.

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