Online Journal of Neurology and

L UPINE PUBLISHERS Brain Disorders

Open Access DOI: 10.32474/OJNBD.2018.02.000127

ISSN: 2637-6628 Review Article

A Double-Blind Placebo-Controlled Trial of

Acediprol (Valproate Sodium) For Global
Severity in Child Autism Spectrum Disorders
NA Aliyev1* and ZN Aliyev2
1
Department of psychiatry and addiction, Azerbaijan State Advanced Training Institute, Azerbaijan
2
Department of psychiatry, Azerbaijan Medical University, Azerbaijan

Received: September 22, 2018; Published: September 28, 2018

*Corresponding author: Nadir A Aliyev, Department of psychiatry and addiction, Azerbaijan State Advanced Training Institute, Baku,
Azerbaijan, Email:

Abstract
Objectives: The effects of Valproate sodium and placebo on global severity were compared in Child Autism Spectrum Disorders
(ASD).
Materials and Methods: Childs with ASDs were enrolled in a 12-week double-blind placebo-controlled Valproate sodium trial.
Fifty were randomly assigned to Valproate sodium (n=50) or placebo (n=50). The initial dose of Valproate sodium for children is
15mg/kg, then increases by 5-10mg/kg every week to 20-50mg/kg. Children are given 5% syrup (Sirupus Valproate sodium 5%), 1
ml 50mg. Repetitive behaviors were measured with the Clinical Global Impression (CGI) improvement scale.
Results: There was a significant treatment-by-time interaction indicating a significantly greater reduction in repetitive
behaviors across time for Valproate sodium than for placebo. With overall response defined as a CGI global improvement score of 2
or less, there were significantly more responders at week 12 in the Valproate sodium group than in the placebo group. The risk ratio
was 1.5 for CGI global improvement (responders: Valproate sodium, 80%; placebo, 12%). Side effects were not observed.
Conclusion: Valproate sodium treatment, compared to placebo, resulted in significantly greater improvement in global severity
behaviors, according to CGI rating scale. Valproate sodium appeared to be well tolerated movement score of 2 or less, there were
significantly more responders at week 12 in the Valproate sodium group than in the placebo group. The risk ratio was 1.5 for CGI
global improvement (responders: Acedipro, 80%; placebo, 12%). Side effects were not observed.

Introduction
studies conducted over the past 50 years, the prevalence of autism
Currently, disorders of the autism spectrum are the most
spectrum disorders (ASD) appears to be increasing globally.
urgent problem of modern psychiatry. It is no accident that the
There are many possible explanations for this apparent increase,
Sixty-Seventh World Health Assembly adopted a resolution
including improved awareness, expansion of diagnostic criteria,
called “WHA67.8 Integrated and coordinated efforts to combat
better diagnostic tools and improved reporting. It is estimated that
autism spectrum disorders.” In particular, the document says:
worldwide 1 in 160 children has an ASD. Other authors indicated
“Understanding that autism spectrum disorders are developmental
that autism spectrum disorder currently estimated to affect
disorders and conditions that emerge in early childhood and,
between 1 and 1.5% of children and adults worldwide [2,3]. In
in most cases, persist throughout the lifespan and are marked
other hand, the cost of supporting an individual with an ASD and
by the presence of impaired development in social interaction
intellectual disability during his or her lifespan was $2.4 million in
and communication and a restricted repertoire of activity and
the United States and £1.5 million (US $2.2 million) in the United
interest, with or without accompanying intellectual and language
Kingdom. The cost of supporting an individual with an ASD without
disabilities; and that manifestations of the disorder vary greatly
intellectual disability was $1.4 million in the United States and
in terms of combinations and levels of severity of symptoms”
£0.92 million (US $1.4 million) in the United Kingdom [4].
[1]. In one hand, last several decades based on epidemiological

Citation: NA Aliyev, ZN Aliyev. A Double-Blind Placebo-Controlled Trial of Acediprol (Valproate Sodium) For Global Severity in Child Autism
Spectrum Disorders. On J Neur & Br Disord 2(1)- 2018. OJNBD. MS.ID.000127. DOI: 10.32474/OJNBD.2018.02.000127.
93
On J Neur & Br Disord Copyrights@ NA Aliyev, et al.

It is known that autism spectrum disorder, previously known d) The subject’s informed consent about participation in the
as the pervasive developmental disorders, is a phenotypically research was received.
heterogeneous group of neurodevelopmental syndromes, with
The decision of the Ethical Committee at the Azerbaijan
polygenic heritability, characterized by a wide range of impairments
Psychiatric Association on the article of NA. Aliev, Z.N. Aliev
in social communication and restricted and repetitive behaviors.
“A Double-Blind Placebo-Controlled Trial of Valproate sodium
Prior to the development of the Fifth Edition of the American
(Valproic Acid) for Global Severity in Child Autism Spectrum
Psychiatric Association’s Diagnostic and Statistical Manual of Mental
Disorders” submitted for publication in psychiatric journals: in
Disorders (DSM-5), autism spectrum disorder was conceptualized
connection with compliance with its legislative requirements and
as five discrete disorders, including: autistic disorder, Asperger’s
regulatory documents is to approve the article by N.A. Aliyev, Z.N.
disorder, childhood disintegrative disorder, Rett syndrome, and
Aliev “A Double-Blind Placebo-Controlled Trial of Valproate sodium
pervasive developmental disorder not otherwise specified [5].
for Global Severity in Child Autism Spectrum Disorders”. We
Autistic disorder was characterized by three core symptom areas:
examined 100 patients with (FI0.239). Patients were observed at
impairments in three domains: social communication, restricted
the Mental Health Center of the Ministry of Health of the Republic
and repetitive behaviors, and aberrant language development
of Azerbaijan (from January 2012 to December 2017 years). Fifty
and usage. Medications are mainly used to treat the associated
subjects were children aged 5–17 years, outpatients, who met
symptoms of an autism spectrum disorder, as the effectiveness of
DSM-V diagnostic criteria for autistic disorder. Subjects had to be
use in treating the main symptoms of autism is not established.
at least moderately ill (CGI-Severity score of at least - 4) to justify
In addition to psychosocial therapy of autism, there are data in
exposure to this medication.
the literature on the use of typical (haloperidol) and atypical
antipsychotics (risperidone, aripiprazole, olanzapine, lurasidone, We excluded sexually active subjects with active or unstable
quetiapine, ziprasidone, paliperidone), antidepressants (selective epilepsy, other genetic syndromes or congenital infections
serotonin reuptake inhibitors and others), mood stabilizers, associated with autistic-like syndromes, prematurity; subjects
stimulants (stimulants / atomoxetine / alpha-2 agonists) and other who have been treated within the previous 30 days by any
agents for the treatment of autism spectrum disorders [6]. The aim medication known to have a clearly defined potential for toxicity
of this study was examining the effects of Valproate sodium and or with any psychotropic drugs; Subjects with clinically significant
placebo on global severity were compared in child autism spectrum abnormalities in laboratory tests or physical examination;
disorders (ASD). subjects with a history of hypersensitivity or serious side effects
associated with the use of Valproate sodium (or other ineffective
Materials and Methods
previous therapeutic tests of Valproate sodium ((serum levels
In accordance with the Helsinki Declaration of the World in the range of 50-100μg /mL for 6 weeks); and subjects who,
Medical Association “Recommendations for doctors engaged in during the previous 3 months, started new non-pharmacological
biomedical research involving people”, adopted by the 18th World procedures, such as diet, vitamins and psychosocial therapy. A
Medical Assembly (Finland, 1964, revised in Japan in 1975, Italy detailed clinical interview with parents by a clinical expert,
- 1983, Hong Kong - 1989, the South African Republic - 1996, accompanied by physical examination and blood analysis, was
Edinburgh - 2000); The Constitution of the Republic of Azerbaijan, used to ensure that subjects did not meet any exclusion criteria.
the Law “On Psychiatric Assistance” (adopted on 12.06.2001, with The method of randomization was given by lottery. This was a
amendments and additions -11.11.2011, Decisions of the Cabinet of 12-week randomized double-blind, placebo-controlled trial.
Ministers of the Republic of Azerbaijan No. 83, dated April 30, 2010 Participants were randomized to Valproate sodium vs placebo
“On Approval of the Rules for Conducting Scientific, Preclinical and and the dose was titrated up according to body weight (Table
Clinical studies of medicines” are established. The conditions of 1). Therapeutic blood level (a minimum valproate blood level
the conducted researches corresponded to the generally accepted of 50μg/ml, as is the established minimum for epilepsy), and
norms of morality, the requirements of ethical and legal norms, as ultimately treatment response. All clinicians involved in efficacy
well as the rights, interests and personal dignity of the participants or safety assessments were blinded to the randomization
of the studies were observed. condition. Efficacy measures were administered every 2 weeks
by an independent evaluator, who was an experienced clinical
a) Conducted research is adequate to the topic of research
psychologist blinded to side effects. Side effects were monitored
work.
by study physicians, who are experienced in treating children
b) There is no risk for the subject of research. with ASD and using Valproate sodium formulations. The dose was
titrated on the basis of feedback from a nonblinded physician who
c) Participants in the study were informed about the goals,
independently monitored blood. This clinician had no contact
methods, expected benefits of the study and associated with risk
with the participants. All valproate levels and safety blood results
and inconvenience in the study.

Citation: NA Aliyev, ZN Aliyev. A Double-Blind Placebo-Controlled Trial of Acediprol (Valproate Sodium) For Global Severity in Child Autism 94
Spectrum Disorders. On J Neur & Br Disord 2(1)- 2018. OJNBD. MS.ID.000127. DOI: 10.32474/OJNBD.2018.02.000127.
On J Neur & Br Disord Copyrights@ NA Aliyev, et al.

were forwarded to him by the laboratory. He then instructed the with such an improvement were not considered responders. A
study physicians to decrease, maintain, or increase the dose. physical examination was conducted at baseline and end visits.
Feedback on subjects randomized to placebo was based on a Blood monitoring of hematopoietic, liver, and renal function was
blocked schedule, so that all study clinicians remained blinded to carried out at baseline, weeks 2 and 4, and at end visit. Weight,
the condition of randomization. height, and BMI were recorded at baseline and at end visit and
Table 1: Titration Schedule (Valproate sodium vs Placebo for vital signs were taken at baseline, weeks 2 and 4, and at end visit.
the Treatment of Children with Autism Spectrum Disorders). Adverse event monitoring took place every week for the first 4
a
Based on clinical response in conjunction with minimum weeks and every 2 weeks thereafter. Questioning was focused
valproate sodium level (50μg/ml). on known side effects of Valproate sodium, followed by open-
<40 kg >40 kg
ended questioning. Valproate sodium was well tolerated within
this group. Side effects were not observed. Expected numbers
Week Dose Dose
indication in the brackets, χ2analysis = 22.68, df = 1. P < 0.001.
Week 0, days 1–4 125mg po QHS 250mg po QHS
There was a significant treatment-by-time interaction indicating a
Week 0, days 5–7 125mg po BID 250mg po BID
significantly greater reduction of ASD generally symptoms across
125mg po QAM, 250mg po QAM,
Week 1, days 1–4 time for Valproate sodium than for placebo. With overall response
250mg po QHS 500mg po QHS
Week 1, days 5–7 250mg po BID 500mg po BID defined as a CGI global improvement score of 2 or less, there were
Titrated to Titrated to
significantly more responders at week 12 in the Valproate sodium
Weeks 2–3 therapeutic drug therapeutic drug group than in the placebo group. The risk ratio was 1.5 for CGI
levela levela global improvement (responders: Valproate sodium, 80%; placebo,
Maintained on Maintained on 12%). Side effects were not observed (Table 2).
Weeks 4–12
therapeutic dose therapeutic dose
Table 2: Results of the Treatment (observed and expected
The dose for children is selected individually depending on the number from the χ2analysis).
age, the severity of the disease, the therapeutic effect. Usually the
Treatment No
daily dose for children is 20 - 50mg per 1kg of body weight, the highest Improvement Total
Groups Improvement
daily 60mg/kg. Begin treatment with 15mg/kg, then increase the
Acidipirol 40 (15.60) 10 (15.60) 50
dose every 5 to 10mg/kg until the desired effect is achieved. The
Placebo 6 (16.43) 44 (16.43) 50
daily dose is divided into 2 - 3 doses. It is convenient for children
Total 46 54 100
to prescribe the drug in the form of a liquid dosage form - acetiprol
5% syrup (Sirupus Acediproli 5%) containing 50mg of the drug in Discussion
1ml. The necessary amount of syrup is measured with a dosage
This study suggests that Valproate sodium may be effective in
spoon with divisions of 2, 5 and 5ml. Independent samples t-tests
the treatment of ASD. There are several reasons why this may be
were used to determine whether there were baseline differences
the case. First, the GABA-enhancing mechanism of valproate may
between treatment groups on the following potential covariates
be relevant to both the pathophysiology of aggression and that of
baseline severity. Also, was used χ2analysis. Outcome measure:
ASD [7,8]. Second, the documented ability of valproate to inhibit
CGI-I (χ2analysis). Consistent with intent-to treat principles, for
kindling has been proposed as an additional mechanism that may
those subjects missing the week-12 ratings, we imputed their
explain its effectiveness in treating mood lability, and as such,
value on the CGI at week 12 using mixed regression models based
may be particularly important in the treatment of irritability [9].
on the available values from all subjects and all seven time points.
Third, the treatment of underlying epileptiform abnormalities
The predicted scores were then used to classify the subjects as
may contribute to behavioral response. This theory, although
responders or non-responders at week 12 on the basis of the
controversial, is supported by our very preliminary data that
following: CGI<2 (responders) or CGI>2 (nonresponders). χ2 test
showed that children randomized to Valproate sodium (with
was used to compare the response between groups.
epileptiform EEGs were classified as responders. This hypothesis
Results is further supported by a report by some authors [10]. We would
also like to make note of our findings suggesting that therapeutic
We evaluated efficacy using the Clinical Global Impression-
blood levels of Valproate sodium are associated with better
Improvement Scale (CGI-I). The CGI-I is a 7-point improvement
response. The safety profile of Valproate sodium in this study was
scale. Ratings of 1 or 2 (responders) indicate a substantial
very good. One should not assume though that the safety profile
reduction in symptoms, so that a treating clinician would be
of a medication in a short-term study would be reflective of a
unlikely to readily change the treatment regimen. A rating of 3
long-term safety with this medication.
(minimally improved) on the CGI is defined as a slight symptomatic
improvement that is not deemed clinically significant; patients

Citation: NA Aliyev, ZN Aliyev. A Double-Blind Placebo-Controlled Trial of Acediprol (Valproate Sodium) For Global Severity in Child Autism
Spectrum Disorders. On J Neur & Br Disord 2(1)- 2018. OJNBD. MS.ID.000127. DOI: 10.32474/OJNBD.2018.02.000127.
95
On J Neur & Br Disord Copyrights@ NA Aliyev, et al.

The mechanism of action has not been established [11- nature, diagnostic criteria and target-symptoms of this frequent
16], however, it is thought to be related to a direct or secondary and potentially invalidating disorder. Mechanisms underlying the
increase in concentrations of the inhibitory neurotransmitter, pathological characteristics of the ASD have yet to be fully elucidated.
gamma-aminobutyric acid (GABA). Possibly cause by its decreased One of the most widely accepted mediators known to play a
metabolism or decreased reuptake in brain tissues. Another central role in the pathophysiology of anxiety disorders is the
hypothesis is that valproate acts on postsynaptic receptor sites g-aminobutyric acid (GABA) system. Evidence supporting the role of
to mimic or enhance the inhibitory action of GABA. The effect on a dysfunctional GABA system has resulted from clinical experience
the neuronal membrane is not completely understood [9-13]. with the benzodiazepines, as well as subsequent determination
Some studies suggest a possible direct effect on membrane activity of mechanism of action, genetic engineering, and neuromaging
related to changes in potassium conductance [17]. Also, valproate studies of the GABA receptor. Valproate sodium is a sample branched
has been shown in animal studies to block sustained neuronal chain fatty acid that was originally developed for the treatment of
bursting responses by reducing the amplitude of sodium-dependent epilepsy. In addition to its anticonvulsant activity, Valproate sodium
action potentials in a voltage-and use-dependent manner [18,19]. has demonstrated anxiolytic, mood-stabilizing, antimigraine and
Valproate is a weak inhibitor of some hepatic P450 isoenzymes, as antinociceptive effects and has been evaluated in the management of
well as epoxide hydrase and glucuronosyl transferase [16]. various other disorders, particularly psychiatric conditions. These
activities appear to be mediated, at least in part, by its effects on
These activities appear to be mediated, at least in part, by its
GABA - mediated neurotransmission. Valproate sodium increases
effects on GABA- mediated neurotransmission. Valproate sodium
CNS concentrations of GABA, possibly by increasing its synthesis
increases CNS concentrations of GABA, possibly by increasing its
and/or inhibiting its catabolism. Valproate sodium has also been
synthesis and/or inhibiting its catabolism. Valproate sodium has
reported to decrease neurotransmission by the excitatory amino
also been reported to decrease neurotransmission by the excitatory
acids (-hydroxybutryc, aspatic and glutamic acids), to inhibit
amino acids (-hydroxybutryc, aspatic and glutamic acids), to
cell firing induced by Af-methyl-D-aspartate, and to exert a direct
inhibit cell firing induced by Af-methyl-D-aspartate, and to exert a
neuronal membrane depressant effectf via modulation of sodium
direct neuronal membrane depressant effectf via modulation of
and potassium conductance. Valproate sodium is generally well
sodium and potassium conductance. Valproate sodium is generally
tolerated, does not induce hepatic drug metabolism and has a low
well tolerated, does not induce hepatic drug metabolism and has
propensity for interactions with psychotropic agents. However,
a low propensity for interactions with psychotropic agents.
as has been observed with several other antiepileptic drugs, it is
Limitations of our study include the relatively small sample size,
teratogenic and can cause elevated hepatic enzyme levels and rare,
which did not allow for a complete analysis of EEG and valproate
fatal hepatotoxicity [22].
blood level data. In addition, the absence of an EEG record at
the end of the study makes it impossible for investigators to Two limitations should be noted. First, our small study group
determine whether an improvement in EEG patterns correlated and we recommend that these results be replicated in a larger
with treatment response. The choice of the ABC-Irritability group so that effect sizes can be more precisely estimated. Second,
subscale, although a validated measure in ASD, precludes us from it is necessary study of possibility generalizability these data to
making recommendations regarding specific types of aggression girls. Notwithstanding these limitations, this study suggests that,
that may be responsive to Valproate sodium. The fact that only depakine-chrono are efficacious and well tolerated in the treatment
seven children had previous exposure to an atypical antipsychotic ASD. In any event, pending a further understanding of valproate’s
also did not allow us to explore whether those with previous mechanisms of action, the present data suggest that this drug is a
risperidone treatment were less responsive to valproate vs those useful new agent for the treatment of ASD.
without previous risperidone, and this remains a question for a
future trial.
Author Disclosure Information
The authors declare that the article is submitted on behalf of
To our knowledge, this is the first report of a randomized,
all authors. None of the material in the article has been published
double-blind, placebo-controlled study of a Valproate sodium in the
previously in any form and none of the material is currently
acute Treatment of outpatients with generalized anxiety disorder
under consideration for publication elsewhere other than noted
without of psychiatric comorbidity. Our data suggest that Valproate
in the cover letter to the editor. Authors declare no financial and
sodium is efficacious in the management of acute anxiety disorders,
personal relationship with other people or organizations that could
as the participants had a clinically and statistically significant
inappropriately influence this work. All authors contributed
improvement in anxiety symptoms over 6 weeks of treatment. Our
to and have approved the final article. The authors declare no
data are also consistent with these findings [20,21]. The rational
conflicts of interest. No sponsor provided funding for this study.
use of pharmacological treatment in generalized anxiety disorders
Mental Health Center of the Ministry of Health of the Republic of
is still a matter of debate due to the uncertainties concerning the

Citation: NA Aliyev, ZN Aliyev. A Double-Blind Placebo-Controlled Trial of Acediprol (Valproate Sodium) For Global Severity in Child Autism 96
Spectrum Disorders. On J Neur & Br Disord 2(1)- 2018. OJNBD. MS.ID.000127. DOI: 10.32474/OJNBD.2018.02.000127.
On J Neur & Br Disord Copyrights@ NA Aliyev, et al.

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Citation: NA Aliyev, ZN Aliyev. A Double-Blind Placebo-Controlled Trial of Acediprol (Valproate Sodium) For Global Severity in Child Autism
Spectrum Disorders. On J Neur & Br Disord 2(1)- 2018. OJNBD. MS.ID.000127. DOI: 10.32474/OJNBD.2018.02.000127.
97