“…Eight papers were selected for the review. Three articles were on divalproex sodium; 24,25,27 one each on lamotrigine, 23 topiramate, 31 and sodium valproate 32 respectively; and two on levetiracetam. 26,33 Fig.…”
Section: Resultsmentioning
confidence: 99%
“…Participants with IDD were included in four RCTs, 24–26,32 but IQ data were not presented in the other four. 23,27,31,33 Only one study 32 recruited predominantly children with IDD (24 of the 30 participants) and reported data on the IDD participants separately. Most studies were parallel-design placebo-controlled double-blind RCTs, except for one which was single-blind and not placebo-controlled.…”
Section: Resultsmentioning
confidence: 99%
“…Most studies were parallel-design placebo-controlled double-blind RCTs, except for one which was single-blind and not placebo-controlled. 33 One study was a non-inferiority study in which divalproex sodium was compared with risperidone rather than placebo, 27 and one was an add-on study where either topiramate or placebo was added to risperidone. 31 Five studies (63%) 23–26,32 were from the USA and there was one each from China, 33 Ukraine 27 and Iran, 31 respectively.…”
Section: Resultsmentioning
confidence: 99%
“…33 One study was a non-inferiority study in which divalproex sodium was compared with risperidone rather than placebo, 27 and one was an add-on study where either topiramate or placebo was added to risperidone. 31 Five studies (63%) 23–26,32 were from the USA and there was one each from China, 33 Ukraine 27 and Iran, 31 respectively. Of the eight studies, four (50%) were part-funded by pharmaceutical companies; 23,24,26,32 however, the source of funding was not mentioned in two studies (25%) and, therefore, sponsorship by pharmaceutical companies could not be ruled out.…”
Section: Resultsmentioning
confidence: 99%
“…approached authors of five included studies asking for missing data, but as none of them responded, data from these RCTs on the Overt Aggression Scale (OAS)/OAS-modified (OAS-M) and Clinical Global Impression Scale-improvement (CGI-I) could not be pooled for meta-analysis. 23–27…”
Background
Despite the widespread use of psychotropic medications in people with autism spectrum disorder (ASD), there is limited evidence to suggest that psychotropic medications including mood stabilisers are effective in individuals with ASD.
Aims
To carry out a systematic review and meta-analysis of randomised controlled trials (RCTs) that assessed the effectiveness of mood stabilisers in people with ASD.
Method
We searched the following databases: Cochrane Library, MEDLINE, Embase, CINAHL, PsycINFO, ERIC, DARE, and ClinicalTrials.gov. In addition, we hand-searched 12 relevant journals. We used the Cochrane Risk of Bias and Jadad scores to assess the quality of included RCTs. We carried out a meta-analysis using a random-effects model.
Results
We included eight RCTs (four on valproate, two on levetiracetam, and one each on lamotrigine and topiramate) that included a total of 310 people with ASD, primarily children. Outcomes were based on core and associated ASD symptoms including irritability and aggression but not bipolar disorder. Only two small studies (25%) from the same group showed definite superiority over placebo and one over psychoeducation alone. Meta-analysis of pooled data on the Aberrant Behaviour Checklist-irritability, Clinical Global Impression Scale-improvement, and Overt Aggression Scale (OAS)/OAS-modified did not show any significant inter-group difference. The rates of adverse effects did not show any significant inter-group difference.
Conclusions
Given the methodological flaws in the included studies and the contradictory findings, it is difficult to draw any definitive conclusion about the effectiveness of mood stabilisers to treat either ASD core symptoms or associated behaviours. Robust large-scale RCTs are needed in the future to address this issue.
PROSPERO registration: CRD42021255467 on 18 May 2021.
“…Eight papers were selected for the review. Three articles were on divalproex sodium; 24,25,27 one each on lamotrigine, 23 topiramate, 31 and sodium valproate 32 respectively; and two on levetiracetam. 26,33 Fig.…”
Section: Resultsmentioning
confidence: 99%
“…Participants with IDD were included in four RCTs, 24–26,32 but IQ data were not presented in the other four. 23,27,31,33 Only one study 32 recruited predominantly children with IDD (24 of the 30 participants) and reported data on the IDD participants separately. Most studies were parallel-design placebo-controlled double-blind RCTs, except for one which was single-blind and not placebo-controlled.…”
Section: Resultsmentioning
confidence: 99%
“…Most studies were parallel-design placebo-controlled double-blind RCTs, except for one which was single-blind and not placebo-controlled. 33 One study was a non-inferiority study in which divalproex sodium was compared with risperidone rather than placebo, 27 and one was an add-on study where either topiramate or placebo was added to risperidone. 31 Five studies (63%) 23–26,32 were from the USA and there was one each from China, 33 Ukraine 27 and Iran, 31 respectively.…”
Section: Resultsmentioning
confidence: 99%
“…33 One study was a non-inferiority study in which divalproex sodium was compared with risperidone rather than placebo, 27 and one was an add-on study where either topiramate or placebo was added to risperidone. 31 Five studies (63%) 23–26,32 were from the USA and there was one each from China, 33 Ukraine 27 and Iran, 31 respectively. Of the eight studies, four (50%) were part-funded by pharmaceutical companies; 23,24,26,32 however, the source of funding was not mentioned in two studies (25%) and, therefore, sponsorship by pharmaceutical companies could not be ruled out.…”
Section: Resultsmentioning
confidence: 99%
“…approached authors of five included studies asking for missing data, but as none of them responded, data from these RCTs on the Overt Aggression Scale (OAS)/OAS-modified (OAS-M) and Clinical Global Impression Scale-improvement (CGI-I) could not be pooled for meta-analysis. 23–27…”
Background
Despite the widespread use of psychotropic medications in people with autism spectrum disorder (ASD), there is limited evidence to suggest that psychotropic medications including mood stabilisers are effective in individuals with ASD.
Aims
To carry out a systematic review and meta-analysis of randomised controlled trials (RCTs) that assessed the effectiveness of mood stabilisers in people with ASD.
Method
We searched the following databases: Cochrane Library, MEDLINE, Embase, CINAHL, PsycINFO, ERIC, DARE, and ClinicalTrials.gov. In addition, we hand-searched 12 relevant journals. We used the Cochrane Risk of Bias and Jadad scores to assess the quality of included RCTs. We carried out a meta-analysis using a random-effects model.
Results
We included eight RCTs (four on valproate, two on levetiracetam, and one each on lamotrigine and topiramate) that included a total of 310 people with ASD, primarily children. Outcomes were based on core and associated ASD symptoms including irritability and aggression but not bipolar disorder. Only two small studies (25%) from the same group showed definite superiority over placebo and one over psychoeducation alone. Meta-analysis of pooled data on the Aberrant Behaviour Checklist-irritability, Clinical Global Impression Scale-improvement, and Overt Aggression Scale (OAS)/OAS-modified did not show any significant inter-group difference. The rates of adverse effects did not show any significant inter-group difference.
Conclusions
Given the methodological flaws in the included studies and the contradictory findings, it is difficult to draw any definitive conclusion about the effectiveness of mood stabilisers to treat either ASD core symptoms or associated behaviours. Robust large-scale RCTs are needed in the future to address this issue.
PROSPERO registration: CRD42021255467 on 18 May 2021.
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