Kusuma Malan e al. Usage o Clozapine in Clinical P ac ice – A C oss-sec ional S udy in a Te ia y Ca e Cen e in India.
In . J Med. Pha m. Res., 6 (6): 247‐252, 2025
247
In e na ional Jou nal o Medical
and Pha maceu ical Resea ch
Online ISSN-2958-3683 | P in ISSN-2958-3675
F equency: Bi-Mon hly
A ailable online on: h ps://ijmp .in/
O iginal A icle
Usage o Clozapine in Clinical P ac ice – A C oss-sec ional S udy in a
Te ia y Ca e Cen e in India
Kusuma Malan1, Zoyanakha Mujahid2, Saga Ka ia3, Sushma Sona ane4
1 Class 1 Psychia is , Regional Men al Hospi al, Thane.
2 Assis an P o esso , Depa men o Psychia y, Fa ookh Academy o Medical Educa ion, Hospi al and Resea ch Ins i u e, Mysu u.
3 Assis an P o esso , Depa men o Psychia y, LTMMC & GH, Sion, Mumbai.
4 Addi ional P o esso , Depa men o Psychia y, LTMMC & GH, Sion, Mumbai
A B S T R A C T
Co esponding Au ho :
D . Saga Ka ia
Assis an P o esso , Depa men o
Psychia y, LTMMC & GH, Sion,
Mumbai.
Recei ed: 14-10-2025
Accep ed: 29-10-2025
A ailable online: 12-11-2025
Backg ound: Clozapine is e y use ul an ipsycho ic in ea men esis an
schizoph enia bu i s use is limi ed due o ea by psychia is s o he li e
h ea ening side e ec s like ag anulocy osis and myoca di is. He eby we conduc ed
his s udy o know he p esc ip ion pa e n, doses, sa e y and e icacy o his d ug.
Ma e ials and Me hods: This was a c oss-sec ional s udy whe ein pa ien s who
we e on clozapine o a leas a week we e in e iewed. Demog aphic de ails and
de ails ega ding clozapine (indica ion o use, s a ing dose, maximum dose,
main enance dose, side e ec s) we e collec ed. Da a was analysed using app op ia e
s a is ical es s. Resul s: 150 pa ien s we e en olled in ou s udy. Maximum had
diagnosis o schizoph enia and ela ed diso de s (73.3%). Minimum dose used was
12.5 mg and maximum dose o 400mg was used in ou s udy. Main indica ion o
s a clozapine was ea men esis ance (53.7%). Main side e ec epo ed was
seda ion (28.7%) ollowed by sialo hea (20.7%). Conclusions: Clozapine is a
well- ole a ed d ug wi h good e icacy and can be used as add-on wi h o he d ugs
sa ely.
Copy igh © In e na ional Jou nal o
Medical and Pha maceu ical Resea ch
Keywo ds: Clozapine, ole abili y, e icacy, side e ec s, dosing.
INTRODUCTION
Second gene a ion an ipsycho ics we e in oduced in clinical p ac ice in ea ly 1900s. Clozapine being he p o o ype o
his g oup was disco e ed su ep i iously by Wande g oup o labo a o ies while sc eening he icyclics o
an idep essan ac i i y bu was di e en ia ed om he es due o i s neu olep ic ac i i y. 1,2
Clozapine use in i s ini ial days showed p omising esul s o he clinicians wi h ewe elapses, lesse need o
hospi aliza ion & es ain s and a be e quali y o li e in hose pa ien s who we e p e iously on o he medica ions. A
phenomenon called awakening was no iced whe e in pa ien s wi h ch onic schizoph enia who we e esis an o ea men
showed symp om emission, comple e unc ional eco e y and esumed wo k. This ga e hope o a be e p ognosis in
ch onic indolen schizoph enia.1,2
Much o he clinicians’ disappoin men clozapine also was associa ed wi h some se ious and a al side e ec s like
ag anulocy osis and myoca di is and some disabling side e ec s like excessi e seda ion and sialo hea. Dea hs being
epo ed due o Ag anulocy osis led o he wi hd awal o he d ug.2
All hese ga e ise o he p essing need o newe d ugs which led o he disco e y o o he a ypical an ipsycho ic d ugs
like Rispe idone, Que iapine, Olanzapine, A ipip azole & Zip asidone.1
Clinicians we e so d eaded by Clozapine in he ini ial yea s, s ingen measu es and s ic moni o ing had o be done
be o e dispensing he d ug. Clozapine go i s FDA app o al in he yea 1990 soon became popula in se e al coun ies.
Kusuma Malan e al. Usage o Clozapine in Clinical P ac ice – A C oss-sec ional S udy in a Te ia y Ca e Cen e in India.
In . J Med. Pha m. Res., 6 (6): 247‐252, 2025
248
Inspi e o se e al s udies like CATIE showing ha clozapine is p obably he mos e ec i e d ug and so many o he
s udies ad oca ing he sa e y o clozapine, i s use is limi ed o only a ela i ely small p opo ion o pa ien s. 1,2
Pe haps his molecule is looked up as a double edged swo d; ou s udy was an a emp o know he p esc ip ion pa e n,
doses, sa e y and e icacy o his d ug. In he ligh o dea h o li e a u e abou his d ug in ecen yea s, he cu en s udy
could be use ul o know mo e abou he d ug & i s usage in a e ia y ca e cen e like ou s.
MATERIALS & METHOD
This s udy was ca ied ou in psychia y ou pa ien depa men o a e ia y heal h ca e ins i u e a e ob aining
Ins i u ional E hics Commi ee app o al. This was a c oss sec ional s udy ca ied ou o a yea and pa ien s who we e on
clozapine o a leas a week and had a eliable in o man wi h hem we e included in he s udy. The su ey ques ionnai e
was used o collec da a a e ob aining w i en in o med consen om he pa icipan s.
Demog aphic de ails and phenomenological de ails like diagnosis, du a ion, co-mo bidi ies, subs ance use, and ques ions
ela ed o clozapine use like eason o s a ing clozapine, s a ing dose, main enance and maximum doses and side
e ec s i any we e collec ed.
Clinical Global Imp ession Scale-Imp o emen (CGI-I) was used o assess he clinical e icacy o clozapine as pe cei ed
by he ela i es a e s a ing he d ug.
The da a ob ained was en e ed in excel shee and analysed using compu e ised so wa e. F equency and pe cen ages we e
calcula ed o ca ego ical a iables and mean and s anda d de ia ion we e calcula ed o con inuous a iables.
Compa isons we e done using Chi-squa e es & - es and p alue o <0.05 was conside ed as s a is ically signi ican .
RESULTS
150 pa ien s we e included in ou s udy. Table 1 desc ibes he demog aphic de ails o s udy popula ion. Ou s udy
comp ised o pa ien s mos ly belonging o he age g oup o 24 o 48 yea s and coming om lowe socio economic s a a
and males being mo e in numbe . Majo i y o pa ien s (70%) who we e on clozapine su e ed om schizoph enia &
ela ed diso de s ollowed by Bipola mood diso de (13%) [Table 2]. Pa ien s wi h MR wi h beha io al issues had been
on clozapine o he longes ollowed by schizoph enia and ela ed diso de s. Diabe es was he mos common co-mo bid
medical condi ion ollowed by hype ension. Mo e han hal (53.7%) o he s udy popula ion had o be s a ed on
clozapine in iew o ea men esis ance, nex mos common indica ion being ex a py amidal side e ec s. A ound 10%
o pa ien s we e s a ed on clozapine as hey we e ac i ely suicidal [Table 3]. Table 4 desc ibes he dose o clozapine
ecei ed by s udy popula ion. Majo i y o he pa ien s (90.6%) had a mean s a ing dose o abou 25mg o clozapine and
majo i y (30%) we e main ained a 100mg. Maximum dose o clozapine used in ou s udy was 400mg. Mo e han 85% o
he s udy popula ion had pe cei ed imp o emen o g ade 1 and 2 and abo e on CGI imp o emen scale [Table 5]. Mos
common side e ec obse ed was seda ion ollowed by sialo hea [Table 6].
TABLES:
Table 1: Demog aphic de ails o ou s udy popula ion:
Table 2: Du a ion o illness & clozapine use in a ious diso de s:
Pa ame e
Schizoph enia &
ela ed diso de s
Bipola mood
diso de
Majo dep essi e
diso de
MR wi h
beha io al
issues
P alue
Du a ion o illness
(in yea s)
12.33 ± 9.75
10.33 ± 11.88
6.93 ± 5.28
9.83 ± 5.67
0.202
Du a ion o clozapine
use (in yea s)
3.59 ± 4.38
1.76 ± 1.92
1.14 ± 1.12
7.34 ± 7.10
0.005*
Pa ame e (N = 150)
Mean ± S.D./ F equency (%)
Age (in Yea s)
34.64 ± 12.61 (14 - 68)
Educa ion (in Yea s)
9.12 ± 5.36 (0 - 43)
Gende
Male
115 (76.7%)
Female
35 (23.3%)
Ma i al S a us
Ma ied
85 (56.7%)
Unma ied
65 (43.3%)
Religion
Hindu
120 (80%)
Non-Hindu
30 (20%)
P ima y Schooling
7 (6.3%)
Kusuma Malan e al. Usage o Clozapine in Clinical P ac ice – A C oss-sec ional S udy in a Te ia y Ca e Cen e in India.
In . J Med. Pha m. Res., 6 (6): 247‐252, 2025
249
Table 3: Reason o s a ing clozapine:
Indica ion (N=150)
F equency
Pe cen
T ea men esis ance
86
53.7
EPR
27
18
Suicidal hough s
14
9.3
Agg ession
8
5.3
Ta di e dyskinesia
7
4.7
Nega i e symp om
4
2.7
Pa kinson’s disease
3
2.0
Insomnia
1
0.7
Table 4: Dose o clozapine in s udy popula ion:
N=150
Mean ± SD
Range
S a ing Dose
26.16mg ± 12.06
12.5 –150mg
Main enance Dose
112.83mg ± 69.377
25 – 350mg
Maximum Dose
119.83mg ± 72.543
25 – 400mg
Table 5: E icacy o clozapine in s udy popula ion:
CGI
Imp o emen
Diagnosis
Schizoph enia & ela ed
diso de s
Bipola mood
diso de
Majo dep essi e
diso de
MR wi h
beha io al issues
1
69
13
10
0
2
31
4
4
4
3
4
2
1
1
4
6
0
0
1
To al
110
19
15
6
Table 6: Side e ec s obse ed wi h clozapine in s udy popula ion:
Side e ec s
Numbe o pa ien s (%)
Seda ion
43 (28.7)
Sialo hea
31 (20.7)
Giddiness
13 (8.7)
Weigh gain
1 (0.7)
Con usion
1 (0.7)
DISCUSSION
Clozapine is e ec i e in ea ing bo h posi i e and nega i e ea u es; has an uppe hand o e o he a ypical
an ipsycho ics because o i s almos nil p opensi y o cause EPR and abili y o ea Ta di e dyskinesia. A s udy done by
Fi on A & Heel RC co obo a es hese p ope ies o clozapine.2 I is one o he mos essen ial ne e heless mos ea ed
a ypical an ipsycho ic in clinical p ac ice. In a s udy done by Mo ime A e al. only o e a hal o pa ien s wi h ea men
esis ance ecei ed clozapine.3
Ne e heless i is also associa ed wi h un a o able side e ec s such as excessi e seda ion, giddiness, seizu es, weigh
gain and insulin esis ance which a e also isk ac o s o Type II Diabe es melli us and ca dio ascula diseases. In a
simila na u alis ic s udy done by Hende son DC e al., 36.6% o he pa ien s de eloped Diabe es melli us o e a 5 yea
ollow up. 4
In ou s udy, majo i y o he popula ion belonged o he age g oup om 24 o 48 yea s. Simila s udies done by Mackin P
e al., & Ciapa elli A e al., also consis ed o people in simila age g oup.5,6
In ou s udy be o e hey we e s a ed on clozapine, mos o he pa ien s had been on a combina ion o 2 o 3 neu olep ics
as well as some adju an d ugs. Then hey we e shi ed o o augmen ed wi h clozapine. Simila o a s udy done by
Howes e al., in which Be o e commencing clozapine, an ipsycho ic polypha macy and high-dose ea men was e iden
in 36.2 and 34.2% o pa ien s espec i ely.7 Majo i y o pa ien s on clozapine had schizoph enia and ela ed diso de s.
The mos common eason o ini ia ing clozapine being ea men esis ance. Also pa ien s wi h schizoph enia had o be
s a ed on clozapine much la e han o he illnesses p obably because clozapine is conside ed no as he i s line in he
ea men . In a su ey done by Kane JM, Leuch S, Ca pen e D, Doche y JP which in ol ed sending ou ques ionnai es
o expe panels, 88% o hem endo sed ispe idone and o he a ypical an ipsycho ics as he i s line o schizoph enia
and clozapine and o he long ac ing a ypical an ipsycho ics as he second choice.8 On he con a y a s udy done by Wang
PS e al., which was a cos bene i analysis o clozapine and o he a ypical an ipsycho ics sugges s ha i is bene icial i
Kusuma Malan e al. Usage o Clozapine in Clinical P ac ice – A C oss-sec ional S udy in a Te ia y Ca e Cen e in India.
In . J Med. Pha m. Res., 6 (6): 247‐252, 2025
250
clozapine is used as a i s line d ug since i would lead o much lesse loss o li es owing o i s an i suicidal p ope y,
educed elapses and no p opensi y o cause EPR.9 Howe e pa ien s wi h bipola mood diso de s in ou s udy had o be
s a ed ea lie & almos hal o pa ien s we e s a ed on clozapine o easons o he han ea men esis ance like
EPR(25%), a di e dyskinesia(10%) & o he s. This is in acco dance wi h his s udy done by Casey e al., which s a es
ha pa ien s wi h a ec i e diso de s a e mo e p one o ge EPR & TD.10
Gi en ha TD is one o he mos dis essing and disabling side e ec s o an ipsycho ics, i is said o be cu ed by
clozapine. 7 pa ien s had been on clozapine exclusi ely o Ta di e dyskinesia. In a s udy done by Spi ak B e al., a he
end o 18 weeks o clozapine ea men , 74% o pa ien s wi h Ta di e dyskinesia and 69% o hose wi h Pa kinsonism
showed imp o emen on AIMS scale & Simpson angus a ing scale o EPS which was s a is ically signi ican .11
In ou s udy mos pa ien s (83.33%) wi h MR wi h beha io al dis u bances ha e been s a ed on clozapine in iew o
EPR. A s udy done by Schei es A e al., Almos hal (44.0%) o 134 in-pa ien adul s wi h ID and beha io al p oblems
had any mo emen diso de .12 Also hey ha e been on clozapine o long ime wi hou any ad e se e ec s. Simila
esul s we e p oduced by a s udy done by Midba i e al., Yalcin O e al., which says ha he hema ological abno mali ies
in he child en we e mos ly ansien , and ha ea men wi h clozapine can be sa ely con inued o enewed and since i
has he leas po en ial o cause EPR & a di e dyskinesia i is he be e choice in child en conside ing he ac ha hei
du a ion o ea men is longe han ha o adul s.13,14
Suicidali y was he majo eason o s a ing clozapine in pa ien s wi h Majo dep essi e diso de in ou s udy.
App oxima ely 50% o pa ien s wi h Schizoph enia and Schizoa ec i e diso de a emp suicide. Mel ze HY e al did a
mul icen e , andomized, 2-yea s udy which compa ed he suicidal isks in Clozapine ea ed pa ien s /s Olanzapine
ea ed pa ien s. In his s udy suicidal beha iou was signi ican ly less in pa ien s ea ed wi h clozapine /s olanzapine,
ewe clozapine ea ed pa ien s a emp ed suicide, equi ed hospi alisa ions o escue in e en ions o p e en suicide o
equi ed concomi an ea men wi h anxioly ics o sni dep essan s.15 This suppo s he use o clozapine o suicidal
hough s in ou s udy.
T ea men esis ance was he indica ion o clozapine in 1 pa ien in his g oup who had OCD wi h se e e agg ession and
sel ha ming beha io who did no espond o op imum ial o bo h ypical and o he a ypical an ipsycho ics. Con a y o
he common belie ha clozapine is known o unmask o agg a a e OC symp oms, a s udy done by Ghaemi SN e al.,
shows ha in 142 andomly selec ed in-pa ien s who we e s a ed on clozapine ea men he e we e no de ini i e cases o
pa ien s who de eloped obsessi e compulsi e diso de (OCD) o whose OCD wo sened as a esul o clozapine
ea men .16
Majo i y o hem we e s a ed wi h 25mg/day and 1 pa ien was s a ed on 150mg/day in iew o agg ession along wi h 2
o he an ipsycho ics. In a e ospec i e analysis o 331 schizoph enics by ola ca a e an a e age o 47 wks o
ea men , agg ession a e had allen down om 31.4% o less han 1.1%.17 Howe e a s udy done by Is yan Bi e e al.,
which was a p ospec i e obse a ional s udy shows ha ispe idone and olanzapine we e supe io o clozapine. And i
also men ions ha he ela i e non esponse o clozapine migh ha e been limi ed o he s udy popula ion alone.18
The s a ing, main enance & maximum dose we e highe in males. In a s udy done by Malalagama G e al., which
in es iga ed he p esc ip ion pa e ns o clozapine in males and emales, i was ound ha majo i y o he sample
popula ion we e males(69%) also hey equi ed a highe dose o clozapine. The mean dose pe age g oup was highe in
males in any age g oup.19
Pa ien s wi h bipola mood diso de equi ed mo e han hose wi h schizoph enia. Pa ien s wi h MR wi h beha io al
issues had ecei ed much lesse doses han he es p obably because o he al eady lowe ed seizu e h eshold in hem. In
a e ospec i e s udy done by Randall D. Buzan e al., only 1 pa ien wi h MR ou o 10 de eloped seizu es on 225mg o
clozapine and he emained seizu e ee on clozapine a e s a ing alp oa e.20
In ou s udy mo e han 50% o he pa ien s pe cei ed imp o emen o G ade IV & abo e on Clinical Global Imp ession
(imp o emen ) scale. A s udy done by John Kane e al., which was a double blind andomized con ol s udy wi h 268
pa ien s wi h ea men esis ance, 33% o pa ien s had emission compa ed o only 4% o pa ien s o chlo p omazine.21
McE o e al. ound ha he pa ien s who we e on d ugs like olanzapine, ispe idone & zip asidone discon inued he use
because o inadequa e e icacy. The ime be o e discon inua ion o clozapine was much longe han o he s 10.5m o
clozapine, 3.3 mon hs o olanzapine.22
Seda ion and sialo hea we e he mos common side e ec s o clozapine ea ed pa ien s in ou s udy. They we e
symp oma ically managed and none o he pa ien s had o s op he d ug because o his. Al hough clozapine is d eaded
o i s side e ec s like ag anulocy osis and myoca di is, none we e epo ed in ou s udy.
Kusuma Malan e al. Usage o Clozapine in Clinical P ac ice – A C oss-sec ional S udy in a Te ia y Ca e Cen e in India.
In . J Med. Pha m. Res., 6 (6): 247‐252, 2025
251
CONCLUSIONS
Ou s udy shows ha clozapine is one o he mos e ec i e an ipsycho ic and e y well ole a ed one. I can be used
sa ely in pa ien s wi h medical como bidi ies and li e h ea ening side e ec s which a e d eaded by majo i y psychia is s
a e a ely encoun e ed in clinical p ac ice.
The limi a ions o ou s udy being c oss sec ional na u e and single cen e ed s udy. Mo e and mo e cen es should
conduc simila s udies o gene a e mo e e idence on he subjec .
Funding: No unding ecei ed
Con lic s o In e es : No con lic o in e es
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