Comparison of the effectiveness of methylphenidate and atomoxetine in the treatment of attention deficit hyperactivity disorder in adult patients

The comparison of effectiveness and adverse effects of Methylphenidate and Atomoxetine in adult ADHD

Clinical trial phase 3, blocked randomized, with sample size of 36 patients, two intervention groups receiving methylphenidate or atomoxetine

Patients with attention deficit hyperactivity disorder are chosen at adult clinic of Roozbeh hospital or psychiatrist's private office. Each patient will randomly receive one of the drugs of methylphenidate or atomoxetin with suitable dosage. Severity of inattentive and hyperactivity symptoms will be analyzed through Conners questionnaire each two weeks for period of two months. Effectiveness and side effects of the drugs is also analyzed through Hamilton depression and anxiety questionnaire, general assessment of functioning scale and drugs adverse effects questionnaire.

Inclusion criteria: Patients with attention deficit hyperactivity disorder; 19-50 years old age Exclusion criteria: History of any other disorders

Intervention group 1: Patients who receive methylphenidate 10 milligram tablets ( Ritalin) manufactured by Novartis pharmaceutical industry in Switzerland three times daily for two months.. Intervention group 2: Patients who receive atomoxetine capsules (Stramox) manufactured by Tadbire kalaye jam pharmaceutical industry n Iran once daily for two months. For both groups the effectiveness and drugs adverse effects is analyzed with suitable questionnaires.

The score of attention deficit hyperactivity disorder in Conners questionnaire, the score of general assessment of functioning index, the score of Hamilton anxiety and depression questionnaire

For designating patients in 2 groups, blocked randomization method is used. The unit of randomization is individual-based and due to the sample size of 36, eighteen of 2-unit blocks are generated. In order to determine the random sequence, “Coin Flip” method is used for assigning the first patient in each block. The first patient is placed in group A if the “head” side is seen as the result of the coin flip and if otherwise, the “tail” is seen, the patient is placed in group B. To generate the random sequence, this process is repeated for next set of blocks until the final patient is designated to the assigned group. To conceal the randomized allocation, the sequentially numbered, opaque sealed envelopes (SNOSE method) is used. 36 opaque numbered envelopes are provided, then each of the sequences is recorded on a card and inserted in an envelope. Finally, the envelopes are placed in a box. At the time of participation of each patient in the trial, the first envelope is opened and the patient 's group is revealed. The random allocation process is done by the hospital pharmacist who does not participate in the study.

It is impossible to blind the physician, patient and data coordinator who is the researcher in this study due to the kind of disease and the medicines. This study is single blinded and the analyzer is unaware of the kind of the medicines given to the patients. The data gathered during the study of patients by the researcher is then unknowingly given to the analyzer and statistics expert.