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A double-blind comparison of Org 3770, amitriptyline, and placebo in major depression.
J Clin Psychiatry 1995; 56(11):519-25JC

Abstract

BACKGROUND

A 6-week, double-blind, dose titration study was performed to evaluate efficacy and safety of the new antidepressant Org 3770 in comparison with amitriptyline and placebo.

METHOD

One hundred fifty outpatients of both sexes, 18 years and older, with a DSM-III diagnosis of major depressive episode, were randomly assigned to 6 weeks of treatment with Org 3770, amitriptyline, or placebo.

RESULTS

At baseline, mean 17-item Hamilton Rating Scale for Depression (HAM-D) scores of all treatment groups were higher than 25, thus indicating that a large proportion of severely depressed patients entered the study. The overall mean daily doses were 22 mg/day for Org 3770, 133 mg/day for amitriptyline, and 4.9 capsules/day for placebo. The majority of times assessments were made, both active drugs produced significantly greater improvements than placebo on all efficacy variables (17-item HAM-D, Montgomery-Asberg Depression Rating Scale, Clinical Global Impressions, and Zung Self-Rating Depression Scale). After 6 weeks of treatment, significantly greater (p < or = .05) proportions of patients in both active treatment groups (70% in the Org 3770- and 58% in the amitriptyline-treatment groups) than in the placebo-treatment group (33%) were HAM-D responders. Org 3770 was well tolerated in this study; dry mouth and somnolence were the only adverse experiences that occurred significantly more frequently with Org 3770- than with placebo-treated patients. By contrast, treatment with amitriptyline was related to significantly higher rates of dry mouth, constipation, and dyspepsia as compared with both Org 3770 and placebo, and significantly higher rates of somnolence as compared with placebo.

CONCLUSION

In this study, Org 3770 was as effective as amitriptyline in the treatment of major depression, with advantages regarding improvements of depressed mood (HAM-D Item 1), responder rates, and safety.

Authors+Show Affiliations

Bremner Research Institute, Olympia, WA 98502, USA.

Pub Type(s)

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

Language

eng

PubMed ID

7592505

Citation

Bremner, J D.. "A Double-blind Comparison of Org 3770, Amitriptyline, and Placebo in Major Depression." The Journal of Clinical Psychiatry, vol. 56, no. 11, 1995, pp. 519-25.
Bremner JD. A double-blind comparison of Org 3770, amitriptyline, and placebo in major depression. J Clin Psychiatry. 1995;56(11):519-25.
Bremner, J. D. (1995). A double-blind comparison of Org 3770, amitriptyline, and placebo in major depression. The Journal of Clinical Psychiatry, 56(11), pp. 519-25.
Bremner JD. A Double-blind Comparison of Org 3770, Amitriptyline, and Placebo in Major Depression. J Clin Psychiatry. 1995;56(11):519-25. PubMed PMID: 7592505.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind comparison of Org 3770, amitriptyline, and placebo in major depression. A1 - Bremner,J D, PY - 1995/11/1/pubmed PY - 1995/11/1/medline PY - 1995/11/1/entrez SP - 519 EP - 25 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 56 IS - 11 N2 - BACKGROUND: A 6-week, double-blind, dose titration study was performed to evaluate efficacy and safety of the new antidepressant Org 3770 in comparison with amitriptyline and placebo. METHOD: One hundred fifty outpatients of both sexes, 18 years and older, with a DSM-III diagnosis of major depressive episode, were randomly assigned to 6 weeks of treatment with Org 3770, amitriptyline, or placebo. RESULTS: At baseline, mean 17-item Hamilton Rating Scale for Depression (HAM-D) scores of all treatment groups were higher than 25, thus indicating that a large proportion of severely depressed patients entered the study. The overall mean daily doses were 22 mg/day for Org 3770, 133 mg/day for amitriptyline, and 4.9 capsules/day for placebo. The majority of times assessments were made, both active drugs produced significantly greater improvements than placebo on all efficacy variables (17-item HAM-D, Montgomery-Asberg Depression Rating Scale, Clinical Global Impressions, and Zung Self-Rating Depression Scale). After 6 weeks of treatment, significantly greater (p < or = .05) proportions of patients in both active treatment groups (70% in the Org 3770- and 58% in the amitriptyline-treatment groups) than in the placebo-treatment group (33%) were HAM-D responders. Org 3770 was well tolerated in this study; dry mouth and somnolence were the only adverse experiences that occurred significantly more frequently with Org 3770- than with placebo-treated patients. By contrast, treatment with amitriptyline was related to significantly higher rates of dry mouth, constipation, and dyspepsia as compared with both Org 3770 and placebo, and significantly higher rates of somnolence as compared with placebo. CONCLUSION: In this study, Org 3770 was as effective as amitriptyline in the treatment of major depression, with advantages regarding improvements of depressed mood (HAM-D Item 1), responder rates, and safety. SN - 0160-6689 UR - https://www.unboundmedicine.com/medline/citation/7592505/A_double_blind_comparison_of_Org_3770_amitriptyline_and_placebo_in_major_depression_ L2 - http://www.diseaseinfosearch.org/result/2199 DB - PRIME DP - Unbound Medicine ER -