Lamotrigine for schizophrenia

Titus Samson Premkumar; Jamie Pick

doi:10.1002/14651858.CD005962.pub2

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Figure 1

Post‐hoc subgroup analysis: Heterogenous data for average change scores (PANSS total scores, high = poor)

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Analysis 1.1

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 1 Global state: 1.Global improvement (CGI‐I).

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Study	Intervention	Least Mean Square	SD	N	Notes
Goff 2006a	Adjuvant lamotrigine	‐0.2	0.82	101
Goff 2006a	Adjuvant placebo	‐0.5	0.82	104
Goff 2006b	Adjuvant lamotrigine	‐0.5	0.72	104
Goff 2006b	Adjuvant placebo	‐0.4	0.72	104

Analysis 1.2

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 2 Global state: 2. Average total change score ‐ short term (CGI‐S, high change=good, data skewed).

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Study	Intervention	Least Square Mean	SD	N	Notes
Goff 2006b	Adjuvant lamotrigine	0.07	7.18	87
Goff 2006b	Adjuvant placebo	‐0.31	7.22	88

Analysis 1.3

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 3 Global state: 3. Average physical health change score ‐ short term (SF‐36, high change=good, data skewed).

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Study	Intervention	Least Square Mean	SD	N	Notes
Goff 2006b	Adjuvant lamotrigine	0.21	8.21	87
Goff 2006b	Adjuvant placebo	1.32	8.16	88

Analysis 1.4

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 4 Global state: 4. Average mental health change score ‐ short term (SF‐36, high change=good, data skewed).

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Analysis 1.5

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 5 Mental state: 1.Treatment responders (> 20% reduction in PANSS total).

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Analysis 1.6

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 6 Mental state: 2a. Average total endpoint score ‐ short term (PANSS, high=poor).

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Analysis 1.7

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 7 Mental state: 2b. Average total endpoint score ‐ short term (BPRS, high=poor).

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Study	Intervention	Least Square Mean	SD	N	Notes
Goff 2006a	Adjuvant lamotrigine	‐6.0	13.77	101
Goff 2006a	Adjuvant placebo	‐8.2	13.84	104
Goff 2006b	Adjuvant lamotrigine	‐12.9	12.34	103
Goff 2006b	Adjuvant placebo	‐12.0	12.40	104

Analysis 1.8

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 8 Mental state: 2c. Average total change score ‐ short term (PANSS, high=poor, data skewed).

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Analysis 1.9

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 9 Mental state: 3a. Average positive endpoint score ‐ short term (PANSS subscale, high=poor).

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Study	Intervention	Least Square Mean	SD	N	Notes
Goff 2006a	Adjuvant lamotrigine	‐2.2	4.39	101
Goff 2006a	Adjuvant placebo	‐3.2	4.51	104
Goff 2006b	Adjuvant lamotrigine	‐4.4	4.18	103
Goff 2006b	Adjuvant placebo	‐3.9	4.20	104

Analysis 1.10

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 10 Mental state: 3b. Average positive change score ‐ short term (PANSS subscale, high change=good, data skewed).

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Analysis 1.11

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 11 Mental state: 4a. Average negative endpoint score ‐ short term (PANSS subscale, high=poor).

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Analysis 1.12

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 12 Mental state: 4b. Average negative endpoint score ‐ short term (SANS, high=poor).

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Study	Intervention	Least Mean Square	SD	N	Notes
Goff 2006a	Adjuvant lamotrigine	‐2.6	12.65	97
Goff 2006a	Adjuvant placebo	‐6.2	13.16	100
Goff 2006b	Adjuvant lamotrigine	‐4.8	11.69	101
Goff 2006b	Adjuvant placebo	‐5.7	11.69	102

Analysis 1.13

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 13 Mental state: 4c. Average negative change score ‐ short term (SANS, high change=good, data skewed).

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Analysis 1.14

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 14 Mental state: 5a. Average general psychopathology endpoint score ‐ short term (PANSS, high=poor).

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Study	Intervention	Least Mean Squares	SD	N	Notes
Goff 2006a	Adjuvant lamotrigine	‐2.4	7.45	101	High change=good
Goff 2006a	Adjuvant placebo	‐3.7	7.48	104
Goff 2006b	Adjuvant lamotrigine	‐5.5	6.63	103
Goff 2006b	Adjuvant placebo	‐5.3	6.56	104

Analysis 1.15

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 15 Mental state: 5c. Average general psychopathology change score ‐ short term (PANSS subscale, data skewed).

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Analysis 1.16

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 16 Mental state: 6a. Average depression endpoint score (HAM‐D 21, high=poor).

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Study	Intervention	Least Square Mean	SD	N	Notes
Goff 2006a	Adjuvant lamotrigine	‐0.2	3.57	97
Goff 2006a	Adjuvant placebo	‐0.8	3.59	101
Goff 2006b	Adjuvant lamotrigine	‐0.8	2.96	100
Goff 2006b	Adjuvant placebo	‐1.2	2.97	102

Analysis 1.17

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 17 Mental state: 6b. Average depression change score (CDSS, high change=good, data skewed).

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Study	Intervention	Least Square Mean	SD	N	Notes
Goff 2006b	Adjuvant lamotrigine	2.7	22.8	86
Goff 2006b	Adjuvant placebo	1.8	22.71	86

Analysis 1.18

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 18 Mental state: 6c. Average depression change score ‐ short term (WHO‐5, high change=good, data skewed).

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Analysis 1.19

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 19 Cognitive state: 1. Treatment response (BACS).

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Analysis 1.20

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 20 Cognitive state: 2. Average change score ‐ short term (Stroop test, high difference from baseline=good).

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Study	Intervention	Least Square mean	SD	N	Notes
Goff 2006a	Adjuvant lamotrigine	0.22	0.61	74
Goff 2006a	Adjuvant placebo	0.23	0.51	84
Goff 2006b	Adjuvant lamotrigine	0.44	0.68	103
Goff 2006b	Adjuvant placebo	0.19	0.70	103

Analysis 1.21

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 21 Cognitive state: 3. Average change score ‐ short term (BACS, high change=good, data skewed).

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Analysis 1.22

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 22 Leaving the study early ‐ short term.

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Analysis 1.23

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 23 Adverse effects: 1. Death, self harm, ideation about harm to self or others ‐ short term.

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Analysis 1.24

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 24 Adverse effects: 2a. Specific ‐ any adverse effect ‐ short term.

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Analysis 1.25

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 25 Adverse effects: 2b. Specific ‐ cardiovascular ‐ short term.

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Analysis 1.26

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 26 Adverse effects: 2c. Specific ‐ dermatological ‐ short term.

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Analysis 1.27

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 27 Adverse effects: 2d. Specific ‐ gastrointestinal ‐ short term.

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Analysis 1.28

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 28 Adverse effects: 2e. Specific ‐ metabolic parameters ‐ short term.

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Analysis 1.29

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 29 Adverse effects: 2f. Specific ‐ neurological ‐ short term.

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Analysis 1.30

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 30 Adverse effects: 2g. Specific ‐ psychiatric ‐ short term.

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Analysis 1.31

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 31 Adverse effects: 2h. Specific ‐ respiratory ‐ short term.

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Analysis 1.32

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 32 Adverse effects: 2i. Specific ‐ others ‐ short term.

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Analysis 1.33

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 33 Adverse effects: 3. Events ‐ co‐incident with trial ‐ short term.

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Study	Intervention	Mean	SD	N	Notes
Akhondzadeh 2005	Lamotrigine	2.93	2.99	18	p=0.78
Akhondzadeh 2005	Placebo	3.25	3.27	18

Analysis 1.34

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 34 Adverse effects: 4a. Movement disorders ‐ average endpoint score (ESRS, high = poor, data skewed).

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Study	Intervention	Mean	SD	N	Notes
Akhondzadeh 2005	Lamotrigine	100.33	81.38	17	p=0.19
Akhondzadeh 2005	Placebo	137.66	87.00	17

Analysis 1.35

Comparison 1 ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO, Outcome 35 Adverse effects: 4b. Movement disorders ‐ average dose (biperiden, mg, high = poor, data skewed).

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Table 1. Suggestions for a trial of lamotrigine for schizophrenia

Methods	Participants	Interventions	Outcomes	Notes
Allocation: centralised sequence generation with table of random numbers or computer generated code, stratified by severity of illness, sequence concealed till interventions assigned. Blinding: those recruiting and assigning participants, those administering intervention, those assessing outcomes, all blind to allocated group, masking by means of identical looking tablets in same schedules. Duration: minimum of 24 weeks.	Diagnosis: schizophrenia (DSM IV), subtypes and schizoaffective disorder included and numbers in each category clearly reported. N=300.* Age: adults. Sex: men and women. Setting: anywhere. History: baseline score on scale such as BPRS or PANSS, stratified by cutoff points into moderate and severe illness, taking routine drugs except lamotrigine or other anticonvulsants. Exclusion: allergy to lamotrigine, pregnant or lactating women, participation in other drug trials.	1. Lamotrigine: dose 400 mg/ day + routine antipsychotic therapy. N=150. 2. Placebo + routine antipsychotic therapy. N=150.	Qualtiy of life: healthy days, SF‐36. Service outcomes: days in hospital, time attending psychiatric outpatient clinic. Satisfaction with care: patients/carers. Global state: CGI.* Mental state: CGI. Functioning. Adverse effects: including mortality. Cognitive function.	* size of study to detect a 10% difference in improvement with 80% certainity. Primary outcome. * If scales are used to measure outcome then there should be binary cut off points, defined before study starts, of clinically important improvement.

Table 1. Suggestions for a trial of lamotrigine for schizophrenia

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Comparison 1. ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: 1.Global improvement (CGI‐I) Show forest plot	1	208	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.73, 1.54]

2 Global state: 2. Average total change score ‐ short term (CGI‐S, high change=good, data skewed) Show forest plot			Other data	No numeric data

3 Global state: 3. Average physical health change score ‐ short term (SF‐36, high change=good, data skewed) Show forest plot			Other data	No numeric data

4 Global state: 4. Average mental health change score ‐ short term (SF‐36, high change=good, data skewed) Show forest plot			Other data	No numeric data

5 Mental state: 1.Treatment responders (> 20% reduction in PANSS total) Show forest plot	3	297	Risk Ratio (M‐H, Random, 95% CI)	1.26 [0.81, 1.97]

6 Mental state: 2a. Average total endpoint score ‐ short term (PANSS, high=poor) Show forest plot	2	67	Mean Difference (IV, Random, 95% CI)	‐16.88 [‐25.18, ‐8.57]

7 Mental state: 2b. Average total endpoint score ‐ short term (BPRS, high=poor) Show forest plot	1	31	Mean Difference (IV, Random, 95% CI)	‐2.80 [‐12.44, 6.84]

8 Mental state: 2c. Average total change score ‐ short term (PANSS, high=poor, data skewed) Show forest plot			Other data	No numeric data

9 Mental state: 3a. Average positive endpoint score ‐ short term (PANSS subscale, high=poor) Show forest plot	2	65	Mean Difference (IV, Random, 95% CI)	‐5.10 [‐8.86, ‐1.34]

10 Mental state: 3b. Average positive change score ‐ short term (PANSS subscale, high change=good, data skewed) Show forest plot			Other data	No numeric data

11 Mental state: 4a. Average negative endpoint score ‐ short term (PANSS subscale, high=poor) Show forest plot	2	67	Mean Difference (IV, Random, 95% CI)	‐5.25 [‐7.07, ‐3.43]

12 Mental state: 4b. Average negative endpoint score ‐ short term (SANS, high=poor) Show forest plot	1	31	Mean Difference (IV, Random, 95% CI)	‐8.80 [‐19.73, 2.13]

13 Mental state: 4c. Average negative change score ‐ short term (SANS, high change=good, data skewed) Show forest plot			Other data	No numeric data

14 Mental state: 5a. Average general psychopathology endpoint score ‐ short term (PANSS, high=poor) Show forest plot	2	67	Mean Difference (IV, Random, 95% CI)	‐10.74 [‐16.53, ‐4.96]

15 Mental state: 5c. Average general psychopathology change score ‐ short term (PANSS subscale, data skewed) Show forest plot			Other data	No numeric data

16 Mental state: 6a. Average depression endpoint score (HAM‐D 21, high=poor) Show forest plot	1	31	Mean Difference (IV, Random, 95% CI)	0.10 [‐3.69, 3.89]

17 Mental state: 6b. Average depression change score (CDSS, high change=good, data skewed) Show forest plot			Other data	No numeric data

18 Mental state: 6c. Average depression change score ‐ short term (WHO‐5, high change=good, data skewed) Show forest plot			Other data	No numeric data

19 Cognitive state: 1. Treatment response (BACS) Show forest plot	2	329	Risk Ratio (M‐H, Random, 95% CI)	1.10 [0.59, 2.04]

20 Cognitive state: 2. Average change score ‐ short term (Stroop test, high difference from baseline=good) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

20.1 Stroop ‐ color naming time	1	36	Mean Difference (IV, Random, 95% CI)	‐29.45 [‐53.69, ‐5.21]
20.2 Stroop ‐ color naming error	1	36	Mean Difference (IV, Random, 95% CI)	‐8.28 [‐12.85, ‐3.71]
20.3 Stroop ‐ word reading time	1	36	Mean Difference (IV, Random, 95% CI)	0.61 [‐10.81, 12.03]
20.4 Stroop ‐ word reading error	1	36	Mean Difference (IV, Random, 95% CI)	‐0.33 [‐2.46, 1.80]
21 Cognitive state: 3. Average change score ‐ short term (BACS, high change=good, data skewed) Show forest plot			Other data	No numeric data

22 Leaving the study early ‐ short term Show forest plot	5	537	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.71, 1.29]

23 Adverse effects: 1. Death, self harm, ideation about harm to self or others ‐ short term Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

23.1 death	2	429	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
23.2 any one or more fatalistic acts/impulses	2	429	Risk Ratio (M‐H, Random, 95% CI)	2.38 [0.90, 6.30]
23.3 suicide attempt	1	217	Risk Ratio (M‐H, Random, 95% CI)	2.97 [0.12, 72.18]
23.4 ideation ‐ homicidal	1	217	Risk Ratio (M‐H, Random, 95% CI)	4.95 [0.24, 102.01]
23.5 ideation ‐ suicidal	2	429	Risk Ratio (M‐H, Random, 95% CI)	1.05 [0.15, 7.06]
24 Adverse effects: 2a. Specific ‐ any adverse effect ‐ short term Show forest plot	2	429	Risk Ratio (M‐H, Random, 95% CI)	1.19 [1.02, 1.38]

25 Adverse effects: 2b. Specific ‐ cardiovascular ‐ short term Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

25.1 chest pain	2	429	Risk Ratio (M‐H, Random, 95% CI)	1.68 [0.18, 15.99]
25.2 electrocardiogram abnormal	1	212	Risk Ratio (M‐H, Random, 95% CI)	3.00 [0.12, 72.82]
25.3 hypertension	1	212	Risk Ratio (M‐H, Random, 95% CI)	2.50 [0.50, 12.60]
25.4 tachycardia	1	212	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 8.09]
26 Adverse effects: 2c. Specific ‐ dermatological ‐ short term Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

26.27 hair loss	1	36	Risk Ratio (M‐H, Random, 95% CI)	3.00 [0.13, 69.09]
26.34 itching	1	36	Risk Ratio (M‐H, Random, 95% CI)	4.0 [0.49, 32.39]
26.45 rash	3	465	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.24, 2.28]
27 Adverse effects: 2d. Specific ‐ gastrointestinal ‐ short term Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

27.1 constipation	1	212	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.04, 3.15]
27.2 decreased appetite	1	217	Risk Ratio (M‐H, Random, 95% CI)	0.11 [0.01, 2.02]
27.3 diarrhea	3	465	Risk Ratio (M‐H, Random, 95% CI)	1.56 [0.39, 6.16]
27.4 dyspepsia	1	212	Risk Ratio (M‐H, Random, 95% CI)	4.0 [0.45, 35.20]
27.5 nausea	3	465	Risk Ratio (M‐H, Random, 95% CI)	2.26 [1.05, 4.88]
27.6 vomiting	2	253	Risk Ratio (M‐H, Random, 95% CI)	3.17 [0.77, 13.02]
28 Adverse effects: 2e. Specific ‐ metabolic parameters ‐ short term Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

28.1 alanine aminotransferase increase	1	217	Risk Ratio (M‐H, Random, 95% CI)	2.97 [0.12, 72.18]
28.2 aspartate aminotransferase	1	217	Risk Ratio (M‐H, Random, 95% CI)	2.97 [0.12, 72.18]
28.3 blood creatine phosphokinase	1	212	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 8.09]
28.4 blood glucose increase	1	212	Risk Ratio (M‐H, Random, 95% CI)	1.5 [0.26, 8.80]
29 Adverse effects: 2f. Specific ‐ neurological ‐ short term Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

29.1 ataxia	1	36	Risk Ratio (M‐H, Random, 95% CI)	5.00 [0.26, 97.37]
29.2 blurred vision	1	36	Risk Ratio (M‐H, Random, 95% CI)	2.0 [0.20, 20.15]
29.3 dizziness	3	465	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.51, 2.70]
29.4 headache	3	465	Risk Ratio (M‐H, Random, 95% CI)	1.36 [0.88, 2.08]
29.5 loss of consciousness	1	212	Risk Ratio (M‐H, Random, 95% CI)	5.0 [0.24, 102.92]
29.6 paraesthesia	1	212	Risk Ratio (M‐H, Random, 95% CI)	3.00 [0.12, 72.82]
29.7 hypoaesthesia	1	212	Risk Ratio (M‐H, Random, 95% CI)	7.00 [0.37, 133.88]
29.8 tremor	1	217	Risk Ratio (M‐H, Random, 95% CI)	4.95 [0.59, 41.71]
30 Adverse effects: 2g. Specific ‐ psychiatric ‐ short term Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

30.1 aggression	1	217	Risk Ratio (M‐H, Random, 95% CI)	2.97 [0.12, 72.18]
30.2 agitation	1	212	Risk Ratio (M‐H, Random, 95% CI)	0.5 [0.09, 2.67]
30.3 anxiety	2	429	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.09, 5.76]
30.4 crying	1	212	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 8.09]
30.5 hallucination, auditory	1	217	Risk Ratio (M‐H, Random, 95% CI)	10.90 [0.61, 194.74]
30.6 insomnia	2	429	Risk Ratio (M‐H, Random, 95% CI)	2.02 [0.04, 96.25]
30.7 paranoia	2	429	Risk Ratio (M‐H, Random, 95% CI)	1.99 [0.37, 10.75]
30.8 somnolence	2	429	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.51, 2.87]
31 Adverse effects: 2h. Specific ‐ respiratory ‐ short term Show forest plot	1	424	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.48, 18.89]

31.1 cough	1	212	Risk Ratio (M‐H, Fixed, 95% CI)	7.0 [0.37, 133.88]
31.2 influenza	1	212	Risk Ratio (M‐H, Fixed, 95% CI)	1.0 [0.06, 15.78]
32 Adverse effects: 2i. Specific ‐ others ‐ short term Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

32.1 abnormal dreams	1	217	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 8.02]
32.2 asthenia	1	217	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 8.02]
32.3 back pain	1	217	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.30, 3.33]
32.4 dry mouth	1	212	Risk Ratio (M‐H, Random, 95% CI)	1.0 [0.21, 4.84]
32.5 fatigue	1	217	Risk Ratio (M‐H, Random, 95% CI)	1.39 [0.45, 4.24]
32.6 lymphadenopathy	2	429	Risk Ratio (M‐H, Random, 95% CI)	2.99 [0.31, 28.48]
32.7 urine abnormality	1	212	Risk Ratio (M‐H, Random, 95% CI)	3.00 [0.12, 72.82]
32.8 weight increase	1	212	Risk Ratio (M‐H, Random, 95% CI)	3.00 [0.12, 72.82]
33 Adverse effects: 3. Events ‐ co‐incident with trial ‐ short term Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

33.1 abscess	1	212	Risk Ratio (M‐H, Random, 95% CI)	3.00 [0.12, 72.82]
33.2 arthropod bite	1	212	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 8.09]
33.3 endometrial cancer	1	212	Risk Ratio (M‐H, Random, 95% CI)	3.00 [0.12, 72.82]
33.5 joint injury	1	217	Risk Ratio (M‐H, Random, 95% CI)	2.97 [0.12, 72.18]
33.6 local swelling	1	217	Risk Ratio (M‐H, Random, 95% CI)	2.97 [0.12, 72.18]
33.7 nasopharyngitis	2	429	Risk Ratio (M‐H, Random, 95% CI)	1.42 [0.28, 7.15]
33.8 pharyngolaryngeal pain	1	212	Risk Ratio (M‐H, Random, 95% CI)	3.00 [0.12, 72.82]
33.9 post‐procedural pain	1	217	Risk Ratio (M‐H, Random, 95% CI)	2.97 [0.12, 72.18]
33.10 tooth abscess	1	217	Risk Ratio (M‐H, Random, 95% CI)	2.97 [0.12, 72.18]
33.11 toothache	1	217	Risk Ratio (M‐H, Random, 95% CI)	0.40 [0.08, 2.00]
33.12 upper respiratory tract infection	2	429	Risk Ratio (M‐H, Random, 95% CI)	1.05 [0.22, 4.94]
34 Adverse effects: 4a. Movement disorders ‐ average endpoint score (ESRS, high = poor, data skewed) Show forest plot			Other data	No numeric data

35 Adverse effects: 4b. Movement disorders ‐ average dose (biperiden, mg, high = poor, data skewed) Show forest plot			Other data	No numeric data

Comparison 1. ADJUNCTIVE LAMOTRIGINE vs ADJUNCTIVE PLACEBO

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