Recognition and early aerobic exercise in prodrome of bipolar disorder: study protocol for a randomized controlled trial

Background: Numerous studies have demonstrated that a long symptomatic prodromal phase (9-12 years) exists before the onset of bipolar disorder. Offspring of patients with bipolar disorders are more likely to present prodromal symptoms compared with those of healthy parents. Methods/Design: This ongoing study is a single-center, randomized parallel-controlled trial. Eligible 120 offspring of patients with bipolar disorder, aged 10-25 years, in the prodromal stage, will be included in this study and randomized to receive psychoeducation or aerobic exercise for 3 months. The primary outcomes are changes in Clinical Global Impressions Scale scores and diagostic status from baseline to 3-month follow-up. The secondary outcomes are changes in Hamilton Depression Rating Scale scores, Young Mania Rating, Brief Psychiatric Rating Scale scores, Hamilton Anxiety Rating Scale scores, Global Assessment Scale scores from baseline to 3-month follow-up. Discussion: The main aim of this study is to identify the prodromal stage of bipolar disorder, and to propose the effective prevention strategies for bipolar disorder. The trial results will provide important clinical evidence for the preventive effect of aerobic exercise on bipolar disorder. Trial registration: ClinicalTrials.gov identifier NCT01863628; registered on 21 May 2013. Ethics: This study protocol was approved by the Ethics Committee of Guangzhou Huiai Hospital, China (approval No. 2016048) and will be performed in accordance with the Declaration of Helsinki. Informed consent: Written informed consent will be obtained from each study participant and his/her legal guardian(s) prior to enrolment.