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Study aim
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Comparison of the effect of risperidone and aripiprazole as a clinical trial in treating the acute phase of mania in patients with bipolar disorders
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Design
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The clinical trial is comparative, with parallel groups, double-blind, randomized, phase 3 on 76 patients, the rand function of Excel software is used for randomization.
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Settings and conduct
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The patients under study are patients who referred to Farshchian Sina Psychiatric Hospital in Hamedan due to bipolar disorders.
The confirmation that these patients have bipolar disorder is done by a psychiatric specialist. The study will be done in a double-blind manner, and the drugs will be delivered to the patients in the same form and appearance.
Coding of the intervention groups is done by one of the experts of the psychiatric department of the hospital, and the research group will be unaware of the coding until the end of the research.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Patient consent to participate in the study
Suffering from the acute phase of mania of bipolar disorder, which must be confirmed by a psychiatrist
Non-entry criteria:
History of hypersensitivity to risperidone and aripiprazole
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Intervention groups
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The number of patients is 76 who are divided into two groups of 38 and the amount of drug consumption in the two research groups is as follows.
In the first group of resperidone, patients will be evaluated at intervals of one week and two weeks.
In the second aripiprazole group, patients will be evaluated at intervals of one week and two weeks.
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Main outcome variables
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Compared to aripiprazole, the effectiveness of risperidone is different in the following cases:
Increased energy, increased mood, increased libido, sleep disturbance, excitability, talkativeness, thought disorder, thought content disorder, aggression, appearance grooming;
Insight into the disease