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Topiramate augmentation in patients with resistant major depressive disorder: a double-blind placebo-controlled clinical trial.

Abstract

BACKGROUND

Despite evolution of new antidepressant treatment, clinicians still encounter challenges in the treatment of depressed patients. Looking for new medications that can potentiate the effects of current antidepressants seems to be necessary. Our objective is to survey the efficacy of topiramate augmentation in resistant major depressive disorder (MDD).

METHOD

This augmentation trial was designed as an 8-week randomized, placebo-controlled, double-blind study. Fifty three patients with DSM-IV diagnosis of MDD who had failed to respond to at least 8 weeks of treatment with an adequate dose of one of the SSRIs (fluoxetine, citalopram or serteraline) were included in the study. Patients were randomized to receive a flexible dose of topiramate (100-200 mg/day) or placebo beside their current antidepressant medication for a period of eight weeks. Outcome measures were Hamilton Depression Scale (HAM-D) and Clinical Global Impression (CGI).

RESULTS

42 patients completed the study and there were 6 and 5 dropouts in topiramate and placebo groups, respectively. The topiramate group demonstrated significant improvement over the study period based on mean HAM-D score at week 8 compared to baseline (P = .000, Z = 3.699). Those receiving topiramate demonstrated to have a mean decrease of 32.0% in HAM-D score, compared to only 5.5% for those receiving placebo. Depressed mood, suicidality, insomnia (early, middle and late), agitation and anxiety symptoms were significantly improved in the topiramate group.

CONCLUSION

Our double-blind placebo-controlled study demonstrated that topiramate augmentation potentiate the efficacy of selective serotonin reuptake inhibitors (SSRIs) in treatment of resistant major depressive disorder. Of note is that our study is preliminary and larger double-blind studies are needed to confirm the results.

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  • Authors+Show Affiliations

    ,

    Department of Psychiatry, Bushehr University of Medical Sciences, Bushehr, Iran. mowlaar@gmail.com

    Source

    MeSH

    Adult
    Citalopram
    Depressive Disorder, Major
    Diagnostic and Statistical Manual of Mental Disorders
    Double-Blind Method
    Drug Resistance
    Drug Therapy, Combination
    Female
    Fluoxetine
    Fructose
    Humans
    Male
    Neuroprotective Agents
    Psychiatric Status Rating Scales
    Serotonin Uptake Inhibitors
    Sertraline
    Topiramate

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    21291943

    Citation

    Mowla, Arash, and Ehsan Kardeh. "Topiramate Augmentation in Patients With Resistant Major Depressive Disorder: a Double-blind Placebo-controlled Clinical Trial." Progress in Neuro-psychopharmacology & Biological Psychiatry, vol. 35, no. 4, 2011, pp. 970-3.
    Mowla A, Kardeh E. Topiramate augmentation in patients with resistant major depressive disorder: a double-blind placebo-controlled clinical trial. Prog Neuropsychopharmacol Biol Psychiatry. 2011;35(4):970-3.
    Mowla, A., & Kardeh, E. (2011). Topiramate augmentation in patients with resistant major depressive disorder: a double-blind placebo-controlled clinical trial. Progress in Neuro-psychopharmacology & Biological Psychiatry, 35(4), pp. 970-3. doi:10.1016/j.pnpbp.2011.01.016.
    Mowla A, Kardeh E. Topiramate Augmentation in Patients With Resistant Major Depressive Disorder: a Double-blind Placebo-controlled Clinical Trial. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jun 1;35(4):970-3. PubMed PMID: 21291943.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Topiramate augmentation in patients with resistant major depressive disorder: a double-blind placebo-controlled clinical trial. AU - Mowla,Arash, AU - Kardeh,Ehsan, Y1 - 2011/02/01/ PY - 2010/09/27/received PY - 2011/01/10/revised PY - 2011/01/22/accepted PY - 2011/2/5/entrez PY - 2011/2/5/pubmed PY - 2011/9/14/medline SP - 970 EP - 3 JF - Progress in neuro-psychopharmacology & biological psychiatry JO - Prog. Neuropsychopharmacol. Biol. Psychiatry VL - 35 IS - 4 N2 - BACKGROUND: Despite evolution of new antidepressant treatment, clinicians still encounter challenges in the treatment of depressed patients. Looking for new medications that can potentiate the effects of current antidepressants seems to be necessary. Our objective is to survey the efficacy of topiramate augmentation in resistant major depressive disorder (MDD). METHOD: This augmentation trial was designed as an 8-week randomized, placebo-controlled, double-blind study. Fifty three patients with DSM-IV diagnosis of MDD who had failed to respond to at least 8 weeks of treatment with an adequate dose of one of the SSRIs (fluoxetine, citalopram or serteraline) were included in the study. Patients were randomized to receive a flexible dose of topiramate (100-200 mg/day) or placebo beside their current antidepressant medication for a period of eight weeks. Outcome measures were Hamilton Depression Scale (HAM-D) and Clinical Global Impression (CGI). RESULTS: 42 patients completed the study and there were 6 and 5 dropouts in topiramate and placebo groups, respectively. The topiramate group demonstrated significant improvement over the study period based on mean HAM-D score at week 8 compared to baseline (P = .000, Z = 3.699). Those receiving topiramate demonstrated to have a mean decrease of 32.0% in HAM-D score, compared to only 5.5% for those receiving placebo. Depressed mood, suicidality, insomnia (early, middle and late), agitation and anxiety symptoms were significantly improved in the topiramate group. CONCLUSION: Our double-blind placebo-controlled study demonstrated that topiramate augmentation potentiate the efficacy of selective serotonin reuptake inhibitors (SSRIs) in treatment of resistant major depressive disorder. Of note is that our study is preliminary and larger double-blind studies are needed to confirm the results. SN - 1878-4216 UR - https://www.unboundmedicine.com/medline/citation/21291943/Topiramate_augmentation_in_patients_with_resistant_major_depressive_disorder:_a_double_blind_placebo_controlled_clinical_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0278-5846(11)00025-X DB - PRIME DP - Unbound Medicine ER -