Clinical Use

Clinical Drug Investigation

, Volume 10, Issue 1, pp 1-7

Efficacy of Dihydroergocristine 20mg Once Daily in Patients with Organic Brain Psychosyndrome

A 3-Month Randomised, Double-Blind, Placebo-Controlled Study
  • A. GuerzoniAffiliated withMedical Department, Mirandola Hospital
  • , S. SantambrogioAffiliated withMedical Department, Mirandola Hospital

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Summary

Forty outpatients (20 men and 20 women) aged 60 to 80 years (mean age 69.9 ±5.5 years) with a diagnosis of organic brain psychosyndrome took part in a 3-month randomised, double-blind study aimed at comparing the effectiveness and safety of dihydroergocristine 20mg once daily and placebo. The patients had experienced memory impairment and reduced concentration and clarity of thought, and/or personality and affective disorders for at least 6 months. Patients had a Hachinski Dementia Score ≤15, a Hachinski Ischemic Score <5, and a Hamilton Rating Scale for Depression score of ≤22. The Sandoz Clinical Assessment-Geriatric (SCAG) scale, used as the efficacy variable, was administered on study entry and during (45 days) and after (90 days) treatment. Safety evaluations (routine laboratory tests and measurements of systolic and diastolic blood pressure and heart rate) were performed before and at the end of the study period. All patients fulfilled the entry criteria and completed the study protocol. In the dihydroergocristine group, there was a marked improvement in the SCAG total score and in most partial scores compared with baseline values. Most symptoms had already improved significantly after 45 days of treatment with dihydroergocristine.

In the placebo group, no clinically relevant or statistically significant changes in SCAG scores relative to baseline values were seen at the end of the study period. Safety was assessed as very good in all patients. No adverse events were reported, except for one case of mild self-limiting nausea during dihydroergocristine treatment. No clinically relevant or statistically significant changes relative to baseline values were found in laboratory parameters or in blood pressure and heart rate measurements performed at the end of each treatment. The results of this study suggest that dihydroergocristine 20mg once daily is effective and safe in the treatment of organic brain psychosyndrome.