Zotepine for schizophrenia

Prasanna DeSilva; Mark Fenton; John Rathbone

doi:10.1002/14651858.CD001948.pub2

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Analysis 1.1

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 1 Death.

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Analysis 1.2

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 2 Global state: 1. Needing additional antipsychotic/sedative drugs.

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Analysis 1.3

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 3 Global state: 2. Not improved or worse (CGI).

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Analysis 1.4

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 4 Global state: 3. Average endpoint score (CGI, higher scores=poor) at 8 weeks.

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Analysis 1.5

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 5 Global state: 4. Hospitalisation.

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Analysis 1.6

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 6 Mental state: 1. No important clinical response ‐ by 4‐12 weeks (20% reduction in BPRS from baseline).

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Analysis 1.7

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 7 Mental state: 2a. Average total endpoint score (BPRS, higher scores=poor).

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Analysis 1.8

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 8 Mental state: 2b. Average total change scores by 8 weeks (PANSS, higher scores=poor, LOCF).

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Analysis 1.9

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 9 Mental state: 3a. Average negative symptom change scores by 8 weeks (PANSS, higher scores=poor, LOCF).

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Analysis 1.10

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 10 Mental state: 3b. Average negative symptom endpoint score (SANS, higher scores=poor).

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Analysis 1.11

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 11 Mental state: 4. Average positive symptom change scores by 8 weeks (PANSS, higher scores=poor, LOCF).

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Analysis 1.12

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 12 Mental state: 5. Average general psychopathology change scores by 8 weeks (PANSS, higher scores=poor, LOCF).

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Analysis 1.13

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 13 Mental state: 6. Average depression change score (MADRS, higher scores=poor, LOCF).

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Analysis 1.14

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 14 Behaviour: Specific behaviour changes.

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Analysis 1.15

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 15 Leaving the study early.

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Analysis 1.16

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 16 Adverse events: 1. Any adverse event.

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Analysis 1.17

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 17 Adverse events: 2. Cardiovascular problems ‐ pulse rate.

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Analysis 1.18

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 18 Adverse events: 3. Gastrointestinal problems ‐ constipation.

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Analysis 1.19

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 19 Adverse events: 4a. Metabolic problems ‐ weight gain.

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Analysis 1.20

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 20 Adverse events: 4b. Metabolic problems ‐ weight change.

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Analysis 1.21

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 21 Adverse events: 5a. Movement disorders ‐ specific problems.

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Study
Cooper 1999a	1. Zotepine group: mean 2.5, SD 3.6. 2. Placebo group: mean 2.8, SD 4.3.

Analysis 1.22

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 22 Adverse events: 5b. Movement disorders ‐ dyskinesia (AIMS, higher scores=poor, skewed data).

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Study
Cooper 1999a	1. Zotepine group: mean 3.9, SD 4.4. 2. Placebo group: mean 2.9, SD 4.4.

Analysis 1.23

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 23 Adverse events: 5c. Movement disorders ‐ parkinsonism (Simpson‐Angus Scale, reduction=good, skewed data).

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Analysis 1.24

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 24 Adverse events: 5d. Movement disorders ‐ change scores by 8 wks (Simpson‐Angus Scale, reduction=good, LOCF).

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Analysis 1.25

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 25 Adverse events: 5e. Movement disorders ‐change score by 8 wks(Tardive Dyskinesia Rating Scale, reduction=good).

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Analysis 1.26

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 26 Adverse events: 6. Sleep problems.

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Analysis 1.27

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 27 Adverse events: 7. Others.

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Analysis 1.28

Comparison 1 ZOTEPINE versus PLACEBO, Outcome 28 Quality of life: Average change score by 8 weeks (SF‐36, high score=better).

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Analysis 2.1

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 1 Global state: 1. Not improved (CGI).

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Analysis 2.2

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 2 Global state: 3. Average endpoint score (CGI, high=poor).

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Analysis 2.3

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 3 Global state: 2. Needing additional antipsychotic/sedative drugs.

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Analysis 2.4

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 4 Mental state: 1. No important clinical response ‐ by 4‐12 weeks.

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Analysis 2.5

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 5 Mental state: 2. Average total endpoint score (BPRS, high=poor).

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Analysis 2.6

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 6 Mental state: 3. Average negative symptom endpoint score (SANS, high=poor).

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Analysis 2.7

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 7 Behaviour: Specific behaviour changes.

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Analysis 2.8

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 8 Leaving the study early: Any reason.

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Analysis 2.9

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 9 Cognition: Not improved (Syndrome Short Test).

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Analysis 2.10

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 10 Adverse events: 1. Any adverse event.

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Analysis 2.11

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 11 Adverse events: 2a. Cardiovascular problems.

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Analysis 2.12

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 12 Adverse events: 2b. Cardiovascular problems ‐ pulse rate.

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Analysis 2.13

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 13 Adverse events: 3. Gastrointestinal problems.

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Analysis 2.14

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 14 Adverse events: 4. Metabolic problems ‐ weight change.

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Analysis 2.15

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 15 Adverse events: 5a. Movement disorders ‐ specific problems.

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Study
Cooper 1999a	1. Zotepine group: mean 2.5. SD 3.6. N=53. 2. Chlorpromazine group: mean 2.9, SD 4.2. N=52.

Analysis 2.16

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 16 Adverse events: 5b. Movement disorders ‐ dyskinesia ‐ endpoint scores (AIMS, high=poor, skewed data).

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Study
Cooper 1999a	1. Zotepine group: mean 3.9, SD 4.4. 2. Chlorpromazine group: mean 4.3, SD 5.5.
Klieser 1996	1. Zotepine: mean 2.6, SD 5.3. N=20. 2. Haloperidol: mean 5.5, SD 5.7. N=45.

Analysis 2.17

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 17 Adverse events: 5c. Movement disorders ‐ parkinsonism (Simpson‐Angus Scale, high=poor, skewed data).

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Analysis 2.18

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 18 Adverse events: 6. Sleep problems.

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Analysis 2.19

Comparison 2 ZOTEPINE versus TYPICAL ANTIPSYCHOTICS, Outcome 19 Adverse events: 7. Others.

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Analysis 3.1

Comparison 3 ZOTEPINE versus ATYPICAL ANTIPSYCHOTICS, Outcome 1 Mental state: 1. Average total endpoint score (BPRS, high=poor).

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Analysis 3.2

Comparison 3 ZOTEPINE versus ATYPICAL ANTIPSYCHOTICS, Outcome 2 Leaving the study early: Any reason.

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Analysis 3.3

Comparison 3 ZOTEPINE versus ATYPICAL ANTIPSYCHOTICS, Outcome 3 Cognition: Not improved (Syndrome Short Test).

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Analysis 3.4

Comparison 3 ZOTEPINE versus ATYPICAL ANTIPSYCHOTICS, Outcome 4 Adverse events: 1a. Movement disorders ‐ needing additional anticholinergic medication.

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Study	Intervention	mean	SD	N
Klieser 1996	Zotepine	2.6	5.3	20
Klieser 1996	Risperidone 8mg group	0.1	2.4	20

Analysis 3.5

Comparison 3 ZOTEPINE versus ATYPICAL ANTIPSYCHOTICS, Outcome 5 Adverse events: 1b. Movement disorders ‐ parkinsonism (Simpson‐Angus Scale endpoint, high=poor, data skewed).

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Table 1. Suggested design for future study

Methods	Participants	Interventions	Outcomes	Notes
Allocation: randomised ‐ clearly described generation of sequence and concealment of allocation. Blinding: double ‐ described and tested. Duration: 6‐12 months minimum.	Diagnosis: schizophrenia (operational or clinical criteria). N=450.* Age: any. Sex: both. History: any.	1. Zotepine: dose ˜ 150‐200 mg/day (clinician's and patent's preference). N=150. 2. Risperidone: dose ˜ 4‐6mg/day. N=150. 3. Perphenazine: dose ˜ 8‐32 mg/day. N=150.	Healthy: time. Leaving study early. Service outcomes: hopsitalised, time in hospital, attending out patient clinics. Global impression: relapse, CGI.* Mental state: BPRS, SANS. Adverse events: DOTES. Quality of life. QoL, employment, family satisfaction, patient satisfaction.	* power calculation suggested 150/group would allow good chance of showing a 20% difference between groups for primary outcome. Primary outcome * All scale‐derived outcomes would have clinically meaningful binary cut off points defined before trial commences.

Table 1. Suggested design for future study

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Comparison 1. ZOTEPINE versus PLACEBO

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Death Show forest plot	1	85	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

2 Global state: 1. Needing additional antipsychotic/sedative drugs Show forest plot	1	85	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.48, 1.14]

3 Global state: 2. Not improved or worse (CGI) Show forest plot	1	85	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.31, 1.10]

4 Global state: 3. Average endpoint score (CGI, higher scores=poor) at 8 weeks Show forest plot	1	106	Mean Difference (IV, Fixed, 95% CI)	‐1.0 [‐1.50, ‐0.50]

5 Global state: 4. Hospitalisation Show forest plot	1	85	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.02, 9.35]

6 Mental state: 1. No important clinical response ‐ by 4‐12 weeks (20% reduction in BPRS from baseline) Show forest plot	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.44 [0.27, 0.72]

7 Mental state: 2a. Average total endpoint score (BPRS, higher scores=poor) Show forest plot	1	105	Mean Difference (IV, Fixed, 95% CI)	‐11.60 [‐18.32, ‐4.88]

8 Mental state: 2b. Average total change scores by 8 weeks (PANSS, higher scores=poor, LOCF) Show forest plot	1	79	Mean Difference (IV, Fixed, 95% CI)	‐4.9 [‐12.36, 2.56]

9 Mental state: 3a. Average negative symptom change scores by 8 weeks (PANSS, higher scores=poor, LOCF) Show forest plot	1	79	Mean Difference (IV, Fixed, 95% CI)	‐0.90 [‐3.49, 1.69]

10 Mental state: 3b. Average negative symptom endpoint score (SANS, higher scores=poor) Show forest plot	1	105	Mean Difference (IV, Fixed, 95% CI)	‐12.5 [‐22.68, ‐2.32]

11 Mental state: 4. Average positive symptom change scores by 8 weeks (PANSS, higher scores=poor, LOCF) Show forest plot	1	79	Mean Difference (IV, Fixed, 95% CI)	‐1.0 [‐2.63, 0.63]

12 Mental state: 5. Average general psychopathology change scores by 8 weeks (PANSS, higher scores=poor, LOCF) Show forest plot	1	79	Mean Difference (IV, Fixed, 95% CI)	‐3.1 [‐7.15, 0.95]

13 Mental state: 6. Average depression change score (MADRS, higher scores=poor, LOCF) Show forest plot	1	79	Mean Difference (IV, Fixed, 95% CI)	‐3.0 [‐5.72, ‐0.28]

14 Behaviour: Specific behaviour changes Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

14.1 agitation	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.48, 1.14]
14.2 hostility	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.48, 1.14]
14.3 nervousness	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.52, 1.18]
15 Leaving the study early Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

15.1 any reason by 8‐26 weeks	3	312	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.63, 0.96]
15.2 due to lack of efficacy by 8‐26 weeks	3	312	Risk Ratio (M‐H, Fixed, 95% CI)	0.37 [0.19, 0.73]
15.3 due to adverse events by 8 weeks	1	85	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.11, 3.05]
16 Adverse events: 1. Any adverse event Show forest plot	2	191	Risk Ratio (M‐H, Random, 95% CI)	1.38 [0.76, 2.52]

17 Adverse events: 2. Cardiovascular problems ‐ pulse rate Show forest plot	1	106	Mean Difference (IV, Fixed, 95% CI)	1.90 [‐1.91, 5.71]

18 Adverse events: 3. Gastrointestinal problems ‐ constipation Show forest plot	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.52, 1.24]

19 Adverse events: 4a. Metabolic problems ‐ weight gain Show forest plot	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.64, 1.45]

20 Adverse events: 4b. Metabolic problems ‐ weight change Show forest plot	1	106	Mean Difference (IV, Fixed, 95% CI)	1.70 [‐3.54, 6.94]

21 Adverse events: 5a. Movement disorders ‐ specific problems Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

21.1 akathisia	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.48, 1.14]
21.2 dyskinesia	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.8 [0.55, 1.17]
21.3 needing additional anticholinergic medication	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.55, 1.22]
22 Adverse events: 5b. Movement disorders ‐ dyskinesia (AIMS, higher scores=poor, skewed data) Show forest plot			Other data	No numeric data

23 Adverse events: 5c. Movement disorders ‐ parkinsonism (Simpson‐Angus Scale, reduction=good, skewed data) Show forest plot			Other data	No numeric data

24 Adverse events: 5d. Movement disorders ‐ change scores by 8 wks (Simpson‐Angus Scale, reduction=good, LOCF) Show forest plot	1	79	Mean Difference (IV, Fixed, 95% CI)	‐0.03 [‐0.12, 0.06]

25 Adverse events: 5e. Movement disorders ‐change score by 8 wks(Tardive Dyskinesia Rating Scale, reduction=good) Show forest plot	1	79	Mean Difference (IV, Fixed, 95% CI)	‐1.2 [‐2.87, 0.47]

26 Adverse events: 6. Sleep problems Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

26.2 insomnia	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.45, 1.01]
26.5 somnolence	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	1.48 [1.06, 2.07]
27 Adverse events: 7. Others Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

27.1 asthenia	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.60, 1.32]
27.2 liver function abnormalities	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.56, 1.29]
27.3 pain	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.62, 1.38]
27.4 saliva increase	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.57, 1.35]
28 Quality of life: Average change score by 8 weeks (SF‐36, high score=better) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

28.1 physical functioning	1	72	Mean Difference (IV, Fixed, 95% CI)	6.90 [‐1.93, 15.73]
28.2 physical role functions	1	72	Mean Difference (IV, Fixed, 95% CI)	20.6 [2.65, 38.55]
28.3 physical pain	1	72	Mean Difference (IV, Fixed, 95% CI)	8.1 [‐6.20, 22.40]
28.4 perception of general health status	1	72	Mean Difference (IV, Fixed, 95% CI)	4.40 [‐2.75, 11.55]
28.5 vitality	1	72	Mean Difference (IV, Fixed, 95% CI)	‐2.5 [‐10.79, 5.79]
28.6 social functioning	1	72	Mean Difference (IV, Fixed, 95% CI)	‐8.5 [‐18.02, 1.02]
28.7 emotional role function	1	72	Mean Difference (IV, Fixed, 95% CI)	15.10 [‐1.96, 32.16]
28.8 psychological well being	1	72	Mean Difference (IV, Fixed, 95% CI)	4.3 [‐1.28, 9.88]
28.9 physical component scale	1	72	Mean Difference (IV, Fixed, 95% CI)	3.60 [‐0.07, 7.27]

Comparison 1. ZOTEPINE versus PLACEBO

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Comparison 2. ZOTEPINE versus TYPICAL ANTIPSYCHOTICS

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: 1. Not improved (CGI) Show forest plot	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.5 [0.11, 2.33]

2 Global state: 3. Average endpoint score (CGI, high=poor) Show forest plot	2	135	Mean Difference (IV, Fixed, 95% CI)	‐0.61 [‐1.01, ‐0.21]

3 Global state: 2. Needing additional antipsychotic/sedative drugs Show forest plot	3	175	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.77, 1.39]

4 Mental state: 1. No important clinical response ‐ by 4‐12 weeks Show forest plot	4	356	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.65, 0.92]

5 Mental state: 2. Average total endpoint score (BPRS, high=poor) Show forest plot	4	234	Mean Difference (IV, Fixed, 95% CI)	‐6.92 [‐11.02, ‐2.83]

6 Mental state: 3. Average negative symptom endpoint score (SANS, high=poor) Show forest plot	2	132	Mean Difference (IV, Fixed, 95% CI)	‐8.66 [‐16.93, ‐0.39]

7 Behaviour: Specific behaviour changes Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1 anxiety +/‐ irritation	2	220	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.67, 1.27]
7.2 hostility	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.8 [0.51, 1.25]
7.3 nervousness	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.52, 1.18]
8 Leaving the study early: Any reason Show forest plot	7	477	Risk Ratio (M‐H, Fixed, 95% CI)	0.83 [0.65, 1.04]

9 Cognition: Not improved (Syndrome Short Test) Show forest plot	1	65	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.13, 0.80]

10 Adverse events: 1. Any adverse event Show forest plot	3	260	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.85, 1.13]

11 Adverse events: 2a. Cardiovascular problems Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

11.1 ECG abnormalities	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	1.44 [0.25, 8.21]
11.2 tachycardia	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	3.83 [0.86, 17.11]
12 Adverse events: 2b. Cardiovascular problems ‐ pulse rate Show forest plot	1	105	Mean Difference (IV, Fixed, 95% CI)	‐1.30 [‐5.38, 2.78]

13 Adverse events: 3. Gastrointestinal problems Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

13.1 anorexia	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	1.44 [0.65, 3.19]
13.2 constipation	3	326	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.73, 1.23]
13.3 nausea	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [0.52, 2.77]
14 Adverse events: 4. Metabolic problems ‐ weight change Show forest plot	1	105	Mean Difference (IV, Fixed, 95% CI)	‐1.30 [‐6.26, 3.66]

15 Adverse events: 5a. Movement disorders ‐ specific problems Show forest plot	6		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

15.1 akathisia	5	396	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.58, 0.93]
15.2 dyskinesia	2	220	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.55, 1.13]
15.3 dystonia	2	70	Risk Ratio (M‐H, Fixed, 95% CI)	0.47 [0.24, 0.93]
15.4 gait disturbance	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.30, 3.09]
15.5 needing additional anticholinergic medication	3	221	Risk Ratio (M‐H, Fixed, 95% CI)	0.65 [0.54, 0.77]
15.6 parkinsonism	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [0.46, 3.93]
15.7 restlessness	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	1.31 [0.67, 2.54]
15.8 rigidity	3	164	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.40, 0.98]
15.9 tremor	4	290	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.46, 1.05]
16 Adverse events: 5b. Movement disorders ‐ dyskinesia ‐ endpoint scores (AIMS, high=poor, skewed data) Show forest plot			Other data	No numeric data

17 Adverse events: 5c. Movement disorders ‐ parkinsonism (Simpson‐Angus Scale, high=poor, skewed data) Show forest plot			Other data	No numeric data

18 Adverse events: 6. Sleep problems Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

18.1 insomnia	3	326	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.66, 1.01]
18.2 lassitude	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	1.13 [0.57, 2.27]
18.3 sleepiness	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	1.56 [0.71, 3.41]
18.4 somnolence	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	1.29 [0.94, 1.76]
19 Adverse events: 7. Others Show forest plot	5		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

19.1 asthenia	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.58, 1.27]
19.2 dry mouth	3	250	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.76, 1.42]
19.3 dizzyness	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.30, 2.26]
19.4 headache	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [0.46, 3.93]
19.5 hyperhydrosis	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.43, 1.80]
19.6 liver function abnormalities	5	396	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.87, 1.38]
19.7 nasal congestion/obstruction	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	3.35 [0.73, 15.31]
19.8 pain	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.60, 1.32]
19.9 salivation increased	1	106	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.52, 1.18]
19.10 slight alterations in EEG	1	34	Risk Ratio (M‐H, Fixed, 95% CI)	1.78 [0.18, 17.80]

Comparison 2. ZOTEPINE versus TYPICAL ANTIPSYCHOTICS

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Comparison 3. ZOTEPINE versus ATYPICAL ANTIPSYCHOTICS

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mental state: 1. Average total endpoint score (BPRS, high=poor) Show forest plot	1	40	Mean Difference (IV, Fixed, 95% CI)	‐1.30 [‐12.95, 10.35]

2 Leaving the study early: Any reason Show forest plot	1	50	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [0.65, 3.15]

3 Cognition: Not improved (Syndrome Short Test) Show forest plot	1	135	Risk Ratio (M‐H, Fixed, 95% CI)	0.70 [0.28, 1.75]

4 Adverse events: 1a. Movement disorders ‐ needing additional anticholinergic medication Show forest plot	1	135	Risk Ratio (M‐H, Fixed, 95% CI)	2.88 [1.22, 6.78]

5 Adverse events: 1b. Movement disorders ‐ parkinsonism (Simpson‐Angus Scale endpoint, high=poor, data skewed) Show forest plot			Other data	No numeric data

Comparison 3. ZOTEPINE versus ATYPICAL ANTIPSYCHOTICS

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