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.
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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)
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Chemical References |
- Delayed-Action Preparations
- Pyrimidines
- Serotonin Receptor Agonists
- ipsapirone
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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
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