kg. NeumPsychophwmamL &Bti Psych&t. 1994. Vol. IS. pp. 616-618

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THERAPEUTIC EFFECTS AND SIDE EFFECTS IN PATIENTS WITH MAJOR DEPRESSION TREATED WITH

SULPIRIDE ONCE A DAY

TOHRU TSUKAMOTO, MIKIO ASAKURA, TOMOHIRO TSUNEIZUMI, YUKO SATOH, TAKAHIRO SHINOZUKA and KAZUO HASEGAWA

Department of Psychiatry St. Marianna University School of Medicine, Kawasaki, Kanagawa, JAPAN

(Final form, May 1993)

Abstract

Tsukamoto Tohru, Mikio Asakura, Tomohiro Tsuneizumi, Yuko Satoh, Takahiro Shinozuka and Kazuo Hasegawa : Therapeutic Effects and Side Effects in Patients with Major Depression Treated with Sulpiride Once a Day. Prog. Neuro-Psychopharmacol. & Biol. Psychiat. 1994, 18(3) 615-618.

1. The effects of once a day dose of sulpiride efficacy and safety was evaluated in patients with major depressive disorder. The patients received sulpiride once a day in the morning or in the evening.

2. There were no significant differences between two groups in the mean measures of efficacy. Side effects were rare and all of a mild degree. The most common side effects were sedation, consti- pation, and dryness of mouth.

3. Out of regard for the administrative and psychological advantage of the once a day dosage this form should be preferred in the treatment of major depression.

Keywords: antidepressant, major depression, once a day dosage, sulpiride

Abbreviations: Hamilton Rating Scale for Depression ( HAM-D ), erectric cardiograph ( ECG ), Diagnostic and Statistical Manual of Mental Disorders, Third Edition-Revised ( DSM-III-R ).

Introduction

The advantage of once a day dosage over administration several times a day of drugs are obvious and generally recognized. It is far more acceptable for the patients to have only one medication a day, and especilly in case of outpatient treatment. The low therapeutic ratio of the tricyclic antidepressants has prompted in- vestigation of new antidepressants, which ideally would have a rapid onset of action, a wide safety margine, and few side effects.

Sulpiride is a benzamide neuroleptics that has been recognized to have antidepressant activity comparable to imipramine, amitripty-

615

616 T. Tsukamoto et al.

line ( Niskanen et al 1975, Nishiura 1976, Corsini et al 1979 ) but fewer side effects ( Tamminga and Gerlach 1967 ). On this background it was found advisable to perform a pilot study with a once a day treatment with sulpiride in patients suffering from major depression.

Methods

Subjects

Study participants had to satisfy the criteria for the depression specified in DSM-III-R, except that the duration of illness had been at least 1 month rather 2 week. Twenty four patients were unipolnr depressive with either single or recurrent episode.

Drug

The fixed doses of sulpiride ( 200mg ) were given during 4 weeks.

Assessment

Hamilton Psychiatric Rating Scale for Depression ( Hamilton 1960 ) was used as a measures of change at week 1, 2, 3, 4 of treatment.

Safety was evaluated with laboratory tests, measurements Of vital

signs, ECGs, physical examinations and recording of all adverse expe-

riances.

Results

Efficacy

Weekly results obtained with the HAM-D are shown in Fig. 1.

22 -

21 -

20 - ii 5 19-

; 18-

2 17-

= 16-

15 -

14 -

13 -

12 -

- Sulpiride in the morning

--- Sulpiride in the evening

Day1 1 2 3 4

Treatment of Weeks

Fig. 1 Hamilton depression rating scale ; mean total score

Therapeutic and side effects of sulpiride 617

From Fig. 1 it may be seen that there were no significant differences between two groups in the mean measures of efficacy. The reduction in HAM-D mean total scores correspond well to the general experiance of the action of effective antidepressants.

Side Effects

Side effects were rare and all of a mild degree. They were most pro- nouced in the 1st week of treatment. The most common side effect were sedation, constipation and dryness of mouth ( Table 1 ). There were no change in the ECGs or in laboratory test results that suggested a pattern of drug-related toxicity.

Table 1

Percentage of Patients Reporting Adverse Experiences

Adverse Experience Percent of Patients Sedation/ Drowsiness 5.2 Constipation 3.4 Dryness of Mouth 4.8 Tremor 2.3

Discussion

The therapeutic results in 24 outpatients who completed treatment with 200mg of sulpiride once a day were even better than normally ob- tained by sulpiride treatment several times a day. Considering the rather limited size of the material it is of course not possible to conclude from the chosen treatment from provides a better effect. However, it is reasonable to suppose that at any rate the effect is not inferior to that of ordinary treatment. Side effects have been very moderate and at least not more pronouced than observed after dosage several times a day.

Conclusion

It should be justifiable to conclude that as regards therapeutic ef- fects as well as side effects sulpiride given once a day is quite as favourable as effective antidepressants.

References

Hamilton, M. (1960) A Rating Scale ror Depression. J. Neurol. Neu- rosurg. Psychiat. 23: 56-62. -

Niskanen, P., Tamminen, T. and Viukari, M. (1975) Sulpiride Versus

Amitriptyline in the Treatment of Depression. Cur-r. Thera. Res. 17: -

281-284.

618 T.Tsukamoto et&.

Nishiura, M. (1976) Clinic-Pharmacological Studies of Sulpiride. Curr. Thera. Res. 20: 164-172. -

Tamminnga, CA. and Gerlach, J. (1987) New Neuroleptics and Experimental Antipsychotics in Schizophrenia. In: Psychopharmacology: The Third Generation of Progress. Meltzer HY. (Eds.), pp 1129-1140, : Raven Press, New York.

Corsini, GU. Del Zompo, M., Melis, GB., Mangoni, A. and Gessa, GL.(1979) (-)Sulpiride as Specific Antagonists of Low-Dose Effects of Apomorphine in Man, In: Sulpiride and Other Benzamide, Spano, PF., Trabucchi, GU. and Gessa, GL. (Eds.), ~~266, Italian Brain Research Foundation Press, Milano.

Inquires and reprint requests should be adressed to:

Dr. Tohru Tsukamoto Department of Psychiatry St. Marianna University 1197-1 Yasashi-cho Asahi-Ku Yokohama 241 Japan