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Risperidone for treatment-refractory major depressive disorder: a randomized trial.
Ann Intern Med 2007; 147(9):593-602AIM

Abstract

BACKGROUND

Major depressive disorder has high prevalence, morbidity, and mortality. Inadequate results with antidepressants have prompts addition of a nonstandard treatment (augmentation therapy).

OBJECTIVE

To assess whether augmentation therapy with risperidone reduces symptoms and increases response to antidepressant therapy and remission of depression in adults.

DESIGN

Multicenter, double-blind, placebo-controlled, randomized trial conducted from 19 October 2004 to 17 November 2005.

SETTING

75 primary care and psychiatric centers.

PATIENTS

274 outpatient adults with major depressive disorder that was suboptimally responsive to antidepressant therapy.

INTERVENTION

After a 4-week run-in period to ensure insufficient response to standard antidepressants, patients were randomly assigned to receive risperidone, 1 mg/d, or placebo for 6 weeks. After 4 weeks, the dosage of risperidone was increased to 2 mg/d in some cases.

MEASUREMENTS

Symptoms were measured by using the 17-item Hamilton Rating Scale for Depression (HRSD-17). Other outcomes were response to therapy, remission of depression, and various clinician- and patient-rated assessments.

RESULTS

Of the intention-to-treat population (268 patients), 81% (111 of 137) who received risperidone and 87.8% (115 of 131) who received placebo completed 6 weeks of double-blind treatment. Mean (+/-SE) HRSD-17 scores improved more in the risperidone augmentation group than in the placebo group (13.4 +/- 0.54 vs. 16.2 +/- 0.53; difference, -2.8 +/- 0.72 [95% CI, -4.2 to -1.4]; P <0.001). More risperidone recipients than placebo recipients experienced remission of depression (24.5% [26 of 106] vs. 10.7% [12 of 112]; P = 0.004) and had a response (46.2% [49 of 106] vs. 29.5% [33 of 112]; P = 0.004). Headache (8.8% of risperidone recipients vs. 14.5% of placebo recipients), somnolence (5.1% vs. 1.5%), and dry mouth (5.1% vs. 0.8%) were the most frequently reported adverse events.

LIMITATIONS

Patients were receiving many different antidepressants, and the duration of augmentation therapy was limited.

CONCLUSION

Risperidone augmentation produced a statistically significant mean reduction in depression symptoms, substantially increased remission and response, and improved other patient- and clinician-rated measures. ClinicalTrials.gov registration number: NCT00095134.

Authors+Show Affiliations

Ortho-McNeil Janssen Scientific Affairs, Titusville, New Jersey, USA. rmahmou@ethus.jnj.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17975181

Citation

Mahmoud, Ramy A., et al. "Risperidone for Treatment-refractory Major Depressive Disorder: a Randomized Trial." Annals of Internal Medicine, vol. 147, no. 9, 2007, pp. 593-602.
Mahmoud RA, Pandina GJ, Turkoz I, et al. Risperidone for treatment-refractory major depressive disorder: a randomized trial. Ann Intern Med. 2007;147(9):593-602.
Mahmoud, R. A., Pandina, G. J., Turkoz, I., Kosik-Gonzalez, C., Canuso, C. M., Kujawa, M. J., & Gharabawi-Garibaldi, G. M. (2007). Risperidone for treatment-refractory major depressive disorder: a randomized trial. Annals of Internal Medicine, 147(9), pp. 593-602.
Mahmoud RA, et al. Risperidone for Treatment-refractory Major Depressive Disorder: a Randomized Trial. Ann Intern Med. 2007 Nov 6;147(9):593-602. PubMed PMID: 17975181.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risperidone for treatment-refractory major depressive disorder: a randomized trial. AU - Mahmoud,Ramy A, AU - Pandina,Gahan J, AU - Turkoz,Ibrahim, AU - Kosik-Gonzalez,Colette, AU - Canuso,Carla M, AU - Kujawa,Mary J, AU - Gharabawi-Garibaldi,Georges M, PY - 2007/11/3/pubmed PY - 2007/12/6/medline PY - 2007/11/3/entrez SP - 593 EP - 602 JF - Annals of internal medicine JO - Ann. Intern. Med. VL - 147 IS - 9 N2 - BACKGROUND: Major depressive disorder has high prevalence, morbidity, and mortality. Inadequate results with antidepressants have prompts addition of a nonstandard treatment (augmentation therapy). OBJECTIVE: To assess whether augmentation therapy with risperidone reduces symptoms and increases response to antidepressant therapy and remission of depression in adults. DESIGN: Multicenter, double-blind, placebo-controlled, randomized trial conducted from 19 October 2004 to 17 November 2005. SETTING: 75 primary care and psychiatric centers. PATIENTS: 274 outpatient adults with major depressive disorder that was suboptimally responsive to antidepressant therapy. INTERVENTION: After a 4-week run-in period to ensure insufficient response to standard antidepressants, patients were randomly assigned to receive risperidone, 1 mg/d, or placebo for 6 weeks. After 4 weeks, the dosage of risperidone was increased to 2 mg/d in some cases. MEASUREMENTS: Symptoms were measured by using the 17-item Hamilton Rating Scale for Depression (HRSD-17). Other outcomes were response to therapy, remission of depression, and various clinician- and patient-rated assessments. RESULTS: Of the intention-to-treat population (268 patients), 81% (111 of 137) who received risperidone and 87.8% (115 of 131) who received placebo completed 6 weeks of double-blind treatment. Mean (+/-SE) HRSD-17 scores improved more in the risperidone augmentation group than in the placebo group (13.4 +/- 0.54 vs. 16.2 +/- 0.53; difference, -2.8 +/- 0.72 [95% CI, -4.2 to -1.4]; P <0.001). More risperidone recipients than placebo recipients experienced remission of depression (24.5% [26 of 106] vs. 10.7% [12 of 112]; P = 0.004) and had a response (46.2% [49 of 106] vs. 29.5% [33 of 112]; P = 0.004). Headache (8.8% of risperidone recipients vs. 14.5% of placebo recipients), somnolence (5.1% vs. 1.5%), and dry mouth (5.1% vs. 0.8%) were the most frequently reported adverse events. LIMITATIONS: Patients were receiving many different antidepressants, and the duration of augmentation therapy was limited. CONCLUSION: Risperidone augmentation produced a statistically significant mean reduction in depression symptoms, substantially increased remission and response, and improved other patient- and clinician-rated measures. ClinicalTrials.gov registration number: NCT00095134. SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/17975181/Risperidone_for_treatment_refractory_major_depressive_disorder:_a_randomized_trial_ L2 - https://www.annals.org/article.aspx?volume=147&amp;issue=9&amp;page=593 DB - PRIME DP - Unbound Medicine ER -