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Indian J.
Psychiat. (1980), 22, 124—126
A C O M P A R A T I V E EVALUATION OF D O T H I E P I N ( P R O T H I E D E N ) A N D IMIPRAMINE M. K. C H A T U R V E D I 1 P. K. AGARWAL 2 N. K. PAREEK' B. K. W A S "
A double-blind controlled comparative trial of Dothiepin was carried out in Psychiatric Hospital, for comparing its efficacy with that of Imipramine, in the treatment of depression and also to compare the incidence and severity of side effects of the two drug;. Dothicpin hydrochloride is a tricyclic anti-depressant d r u g with pharmacological properties common to Imipramine Amitryptline and related drugs. M A T E R I A L AND M E T H O D
T h i r t y patients of depression of both sexes, were included in the study. O u t of these thirty patients 15 were males and 15 were females. T h e age range was between 30 and 50 years. T h e diagnostic pattern in these patients revealed that 12 patients had involutional depression, 10 reactive depression and 8 h a d endogenous depression. Those, having pregnancy, or who have received E . C . T . within the previous 2 months or patients receiving full doses of Prothiadcn or Imipramine before admission to trial, or patients whose pre-trial Hamilton rating score was under 30, were excluded from study. T h e patients were randomly allocated to t r e a t m e n t with either Dothiepin or Imipramine. The initial daily doses of either drug was one tablet (25 mg) thrice daily and was increased later up to 6 tablets (150 mg), depending upon patient's response. 'Clinical Tutor "Senior Registrar 'Senior Registrar (General Medicine) 'Professor and Head of Department,
T h e duration of therapy in all patients was 4 weeks, so as to ensure that the trial r e mained strictly double-blind. T h e details of treatment administered are summarised in T a b l e - 1 . T h e patients were assessed on the Hamilton rating scale, before t r e a t m e n t , daily in the first week a n d at the end of 2nd, 3rd and 4th weeks of treatment. Side effects reported by the patients were also recorded. Laboratory investigations comprising haematological a n d biochemical tests a n d urine analysis were d o n e before and after therapy. OBSERVATIONS AND RESULTS
T h e profile of p a t i e n t s ' study is presented in T a b l e 1. O u t of 30 p a t i e n t s who have completed treatment, 9 had received previous treatment w i t h anti-depressants, of these 7 h a d obtained satisfactory response a n d 2 responded unsatisfactorily. (Table 2). T A B L E 1—Profile
of patients
Dothiepin No. of patients SexMale Female Age— Mean (in yrs.) Range No. of Depressive Attacks— Mean Range
Department of Psychiatry, S.M.S. Medical College, Jaipur.
Imipramine
15
15
7 8
9 6
47.1 30—60 1.55 1—2
45.4 35—57 2.10 1—8
EVALUATION
OF DOTHIEPIN
(PROTHIEDEN)
TABLE 2—Previous treatment with anti-depressant Dothiepin Group
125
& IMIPRAMINE
only one p a t i e n t in the Dothiepin group complained of ataxia a n d giddiness as side
Imipramine Group
effects
( T a b l e 5). T A B L E 5—Side effects
No. of Pts. who had previous treatment Response to treatment—
Dothiepin
Side effects
Number of patients Number of patients who complained of side effects
Satisfactory Equivocal Unsatisfactory
Imipramine 15
15
1
5
Symptoms— (i) (ii) (iii) (iv) (v)
T A B L E 3—Overall response Dothiepin (15)
Group
Imipramine (15)
Pre-Treatment
37.50
36.33
Week I
24.85
27.66
Week I I
20.07
24.50
Week I I I
13.14
16.41
Week IV
7.07
11.33
Dryness of mouth Tremor Constipation Giddiness Palpitation
3 1 2 1 1
1
*3 Patients dropped out due to side effects. DISCUSSIONS
O n statistical analysis of d a t a , it is seen that there is n o significant difference between the two t r e a t m e n t s in terms of overall res-
T A B L E 4—Response of Target Symptoms Mean Hamilton
Score
Assessment Somatic
Anxiety
Insomnia
Depression
period
Dothiepin Imipramine Dothiepin Imipramine Dothiepin
Imipramine Dothiepin
Symptoms Imipramine
Pre-Treatment
9.35
9.58
6.00
6.00
5.09
4.90
4.20
4.08
Week I
6.92
6.50
4.57
4.83
3.45
3.72
2.71
3.50
Week I I
5.57
5.75
4.21
4.41
2.63
3.09
2.07
3.30
Week I I I
3.71
4.25
3.21
3.00
1.36
1.90
1.42
1.41
Week IV
1.92
3.08
1.35
2.25
0.90
1.09
0.50
0.83
T h e mean H a m i l t o n scores recorded in b o t h t h e groups in the cases of overall rating, a n d target symptoms viz. depression, anxiety, insomnia, a n d somatic symptoms arc represented in Tables 3 & 4. T h e Bio-chemical a n d Haematological parameters studied, did n o t reveal any abnormality. T h r e e patients w h o received I m i p r a m i n e developed dryness of mouth and constipation a n d so were dropped out from trial d u e t o side effects, whereas
ponse a n d in t h e response of target symptoms.However, the m e a n percentage r e d u c tion in total score was more with Dothiepin than with I m i p r a m i n e , throughout the treatment period, though b o t h the drugs were effective in t h e t r e a t m e n t of depression. Response of individual target symptoms was also favourable with Dothiepin t h a n w i t h I m i p r a m i n e . T h o u g h side effects encountered were mild, their incidence was more with I m i p r a m i n e t h a n Dothiepin.
126
M . K. C H A T U R V E D I it al.
SUMMARY AND CONCLUSION
A comparative evaluation of Dothicpin (Prothieden) and Imipramine was done. The present study confirms the effectiveness of Dothiepin in the treatment of severe depression and that its tolerability is good, as compared to Imipramine. Thus Dothie-
pin hydrochloride would be a useful addition to drugs available to Psychiatrists. ACKNOWLEDGEMENT
We are thankful to Boots Company (India) Limited, which supplied us the drugs for conducting this trial.
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