A Canadian multicenter study of three fixed doses of controlled-release ipsapirone in outpatients with moderate to severe major depression.

Abstract

Ipsapirone, an azapirone with 5-hydroxytryptamine (5-HT1A) partial agonist activity, has been shown in preliminary studies to be effective in the treatment of major depressive disorder. This 8-week, randomized, double-blind study compared the efficacy, safety, and tolerability of three fixed doses of controlled-release ipsapirone (10-, 30-, and 50-mg dose once daily) with placebo in 410 patients with moderate to severe major depression (Hamilton Rating Scale for Depression [HAM-D] score > or = 20). The 10-mg ipsapirone treatment arm was discontinued early in the study. A total of 390 patients were eligible for evaluation in the intent-to-treat sample. The primary efficacy variable was the change in HAM-D total score from baseline to visit 8. There was no significant difference in efficacy in the two treatment groups versus the placebo group. The overall treatment response, defined as a 50% decrease in the HAM-D total score from baseline, was 43% with ipsapirone 50 mg given once daily, 34% with ipsapirone 30 mg given once daily, and 35% with placebo. In subanalyses, ipsapirone 50 mg given once daily was superior to placebo according to the HAM-D Core Depression (mood, guilt, interest, psychomotor activity) subtotal (p = 0.0453) and Melancholic item (p = 0.0225). Ipsapirone 30 mg given once daily was superior to placebo only in patients with moderate depression (baseline HAM-D total score < or = 25; p = 0.0100). The most common adverse effect in all groups was headache. The only dose-dependent adverse effects were dizziness and nausea.

• Authors: Y D Lapierre, P Silverstone, R T Reesal, B Saxena, P Turner, D Bakish, J Plamondon, P M Vincent, R A Remick, C Kroft, R Payeur, D Rosales, R Lam, M Bologa
• Journal: Journal of clinical psychopharmacology (J Clin Psychopharmacol) Vol. 18 Issue 4 Pg. 268-73 (Aug 1998) ISSN: 0271-0749 [Print] United States
• PMID: 9690691 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Delayed-Action Preparations
• Pyrimidines
• Serotonin Receptor Agonists
• ipsapirone

Topics

• Adolescent
• Adult
• Aged
• Ambulatory Care
• Canada
• Delayed-Action Preparations
• Depressive Disorder, Major (diagnosis, drug therapy, psychology)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Male
• Middle Aged
• Personality Inventory
• Pyrimidines (administration & dosage, adverse effects)
• Serotonin Receptor Agonists (administration & dosage, adverse effects)
• Treatment Outcome