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. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

Ghanizadeh 2013.

Methods An 8‐week parallel trial with 2 arms:
  1. Methylphenidate and folic acid

  2. Methylphenidate and placebo

Participants Number of patients screened: not stated
Number included: 49
Number randomised to methylphenidate + placebo: 26
Number randomised to methylphenidate + folic acid: 23
Number followed up in methylphenidate + placebo: 13
Number of withdrawals in methylphenidate + placebo: 13
Methylphenidate + placebo group
Diagnosis of ADHD: DSM‐IV (subtype: not stated)
Age: mean 9.9, range 5‐16 years old
IQ: no estimated mental retardation
Sex: 23 males, 3 females
Methylphenidate‐naïve: not stated
Ethnicity: not stated
Country: Iran
Comorbidity: not stated
Comedication: not stated
Sociodemographics: not stated
Inclusion criteria
  1. Diagnosis of ADHD according to DSM‐IV

  2. Aged 5 to 16 years

  3. Children and parents providing informed consent


Exclusion criteria
  1. Self‐reported allergic reaction to folic acid

  2. Kidney disease, estimated mental retardation, mild pervasive developmental disorder, infection, anaemia, alcoholism or epilepsy

  3. Being on dialysis

  4. Taking medication such as phenytoin, methotrexate, nitrofurantoin, tetracycline, barbiturates, such as phenobarbital, and antiepileptic medication such as phenytoin or primidone

  5. Diagnosed psychotic disorder or diagnosed mood disorder

  6. Other conditions that preclude participation (or increase risk) in the clinical trial (Type 1 diabetes mellitus, metabolic diseases, gastro‐intestinal disorders affecting nutrient absorption, cancer)

  7. Extensive use of nutritional folic acid supplements within the previous 3 months

  8. Behaviour therapy or any other psychotherapy in the last 3 months or during the study

Interventions Methylphenidate type: not stated
Mean MPH dosage: 10 mg/day (< 25 kg) and 20 mg/day (> 24 kg)
Administration schedule: twice daily
Duration of intervention: 2 months
Treatment compliance: not stated
Outcomes Non‐serious adverse events:
Self‐reported measures upon dropout from study
Notes Sample calculation: yes
Ethics approval: approved by the Shiraz University of Medical Sciences Ethics Committee
 Funding/vested interests/authors' affiliations: not stated
Key conclusions of the study authors: considering the marked limitations of this trial, this report suggests that methylphenidate may improve ADHD symptoms and the quality of life of children with ADHD. Current evidence does not support that folic acid as an adjuvant is effective for treating ADHD symptoms or aggression, or improving quality of life of children with ADHD
Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no