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Ipsapirone: evidence for efficacy in depression.

A H Heller¹, M Beneke, B Kuemmel

¹Department of CNS Medical Research, Miles, Inc., W. Haven, CT 06516.

Psychopharmacology Bulletin

|January 1, 1990

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Ipsapirone significantly improved neurotic depression symptoms compared to placebo over four weeks, as measured by the Hamilton Rating Scale for Depression (HAM-D). However, ipsapirone also showed a higher incidence of treatment-emergent adverse events.

Area of Science:

Psychiatry
Clinical Pharmacology

Background:

Neurotic depression is a significant clinical challenge.
Existing treatments for neurotic depression have limitations.

Purpose of the Study:

To evaluate the efficacy and safety of ipsapirone in treating neurotic depression.
To compare ipsapirone with placebo in a double-blind clinical trial.

Main Methods:

A prospective, double-blind, randomized clinical trial.
Inclusion of 34 inpatients diagnosed with neurotic depression (ICD-9).
Treatment with ipsapirone (7.5 mg t.i.d.) or placebo for 4 weeks.

Main Results:

Ipsapirone demonstrated a statistically significant reduction in HAM-D scores compared to placebo (p < .001).

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The mean change in HAM-D scores was -13.13 for ipsapirone versus -3.19 for placebo.

A higher percentage of patients on ipsapirone reported treatment-emergent adverse events (76%) compared to placebo (38%).

Conclusions:

Ipsapirone shows significant efficacy in treating neurotic depression.
Safety and tolerability profiles require careful consideration due to increased adverse events.