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Oral scopolamine augmentation in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled study.
J Clin Psychiatry 2012; 73(11):1428-33JC

Abstract

OBJECTIVE

To evaluate the antidepressant effect of oral scopolamine as an adjunct to citalopram.

METHOD

In this randomized double-blind placebo-controlled study, patients were assessed in the outpatient clinics of 2 large hospitals from November 2011 to January 2012. Forty patients (18-55 years) with major depressive disorder (DSM-IV-TR criteria) and 17-Item Hamilton Depression Rating Scale (HDRS) score ≥ 22 were randomly assigned to scopolamine hydrobromide (1 mg/d) (n = 20) or placebo (n = 20) in addition to citalopram for 6 weeks. HDRS score was measured at baseline and days 4, 7, 14, 28, and 42. The primary outcome measure was HDRS score change from baseline to week 6 in the scopolamine group versus the placebo group. Response was defined as ≥ 50% decrease in HDRS score; remission, as HDRS score ≤ 7.

RESULTS

Augmentation with scopolamine was significantly more effective than placebo (F(1,38) = 5.831, P = .021). Patients receiving scopolamine showed higher rates of response (65%, 13/20 at week 4) and remission (65%, 13/20 at week 6) than the placebo group (30%, 6/20 and 20%, 4/20, respectively; P = .027, P = .004, respectively). Patients in the scopolamine group showed higher rates of dry mouth, blurred vision, and dizziness than the placebo group.

CONCLUSIONS

Oral scopolamine is a safe and effective adjunct for treatment of patients with moderate to severe major depressive disorder.

TRIAL REGISTRATION

Iranian Registry of Clinical Trials identifier: IRCT201201181556N31.

Authors+Show Affiliations

Psychiatric Research Centre, Roozbeh Hospital, Tehran, Iran.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23146150

Citation

Khajavi, Danial, et al. "Oral Scopolamine Augmentation in Moderate to Severe Major Depressive Disorder: a Randomized, Double-blind, Placebo-controlled Study." The Journal of Clinical Psychiatry, vol. 73, no. 11, 2012, pp. 1428-33.
Khajavi D, Farokhnia M, Modabbernia A, et al. Oral scopolamine augmentation in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2012;73(11):1428-33.
Khajavi, D., Farokhnia, M., Modabbernia, A., Ashrafi, M., Abbasi, S. H., Tabrizi, M., & Akhondzadeh, S. (2012). Oral scopolamine augmentation in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled study. The Journal of Clinical Psychiatry, 73(11), pp. 1428-33. doi:10.4088/JCP.12m07706.
Khajavi D, et al. Oral Scopolamine Augmentation in Moderate to Severe Major Depressive Disorder: a Randomized, Double-blind, Placebo-controlled Study. J Clin Psychiatry. 2012;73(11):1428-33. PubMed PMID: 23146150.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral scopolamine augmentation in moderate to severe major depressive disorder: a randomized, double-blind, placebo-controlled study. AU - Khajavi,Danial, AU - Farokhnia,Mehdi, AU - Modabbernia,Amirhossein, AU - Ashrafi,Mandana, AU - Abbasi,Seyed-Hesammedin, AU - Tabrizi,Mina, AU - Akhondzadeh,Shahin, Y1 - 2012/10/16/ PY - 2012/02/17/received PY - 2012/06/18/accepted PY - 2012/11/14/entrez PY - 2012/11/14/pubmed PY - 2013/2/21/medline SP - 1428 EP - 33 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 73 IS - 11 N2 - OBJECTIVE: To evaluate the antidepressant effect of oral scopolamine as an adjunct to citalopram. METHOD: In this randomized double-blind placebo-controlled study, patients were assessed in the outpatient clinics of 2 large hospitals from November 2011 to January 2012. Forty patients (18-55 years) with major depressive disorder (DSM-IV-TR criteria) and 17-Item Hamilton Depression Rating Scale (HDRS) score ≥ 22 were randomly assigned to scopolamine hydrobromide (1 mg/d) (n = 20) or placebo (n = 20) in addition to citalopram for 6 weeks. HDRS score was measured at baseline and days 4, 7, 14, 28, and 42. The primary outcome measure was HDRS score change from baseline to week 6 in the scopolamine group versus the placebo group. Response was defined as ≥ 50% decrease in HDRS score; remission, as HDRS score ≤ 7. RESULTS: Augmentation with scopolamine was significantly more effective than placebo (F(1,38) = 5.831, P = .021). Patients receiving scopolamine showed higher rates of response (65%, 13/20 at week 4) and remission (65%, 13/20 at week 6) than the placebo group (30%, 6/20 and 20%, 4/20, respectively; P = .027, P = .004, respectively). Patients in the scopolamine group showed higher rates of dry mouth, blurred vision, and dizziness than the placebo group. CONCLUSIONS: Oral scopolamine is a safe and effective adjunct for treatment of patients with moderate to severe major depressive disorder. TRIAL REGISTRATION: Iranian Registry of Clinical Trials identifier: IRCT201201181556N31. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/23146150/Oral_scopolamine_augmentation_in_moderate_to_severe_major_depressive_disorder:_a_randomized_double_blind_placebo_controlled_study_ L2 - http://www.psychiatrist.com/jcp/article/pages/2012/v73n11/v73n1111.aspx DB - PRIME DP - Unbound Medicine ER -