The purpose of the AGTs-BD study is to compare the treatment outcome and safety profiles between different mood stabilizers combination treatments in the patients with bipolar disorders, currently suffered from depression episode.
The AGTs-BD study is a randomized, open-label, rater-blind, multicenter study, which including an 8-week acute treatment (Phase I), followed by a 24-week recurrence prevention treatment (Phase II), and a 24-week relapse prevention treatment (Phase III). Patients initially enter an up to 4 weeks screening phase to confirm the randomization to whom met DSM-IV criteria of bipolar I or II disorder, currently depressed with Hamilton Depression Rating Scale-17 items (HAM-D) total score ≥17. The protocol was approved by the each sites' appropriate institutional review boards and ethics committees. After screening, patients were randomly allocated to one of three groups: (1) lithium monotherapy; (2) lithium plus quetiapine; (3) lithium plus a Traditional Chinese Medicine (TCM) named as Shuganjieyu capsule (SGJY, St. John's wort and acanthopanax senticosus combination). After phase I, patients who met stable remission, defined as HAM-D total score ≤7 and Young Mania Rating Scale (YMRS) total score ≤10 in two consecutive visit at least 4 weeks, were qualified into phase II and III. Patients remained on the allocated treatment for up to 48 weeks or until treatment failure. The difference between phase II and phase III was that treatment dose could be decreased (within the study ranges) if side-effects became troublesome in phase III, but not for phase II. All patients will be provided with free care (3 visits) by the investigators, for a period of up to 3 months after the end of the study, in order to help them make the transition into routine clinical care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
360
Lithium plasma concentration was between 0.6-1.2 mmol/L, dose should be fixed at the end of week 4, and the maximum dosage was judged by the investigator based on the patients' tolerability.
Quetiapine adjunctively to lithium therapy, target 400 mg/d with a minimum dose of 200 mg/d. Dose should be fixed at the end of week 4, and the maximum dosage was judged by the investigator based on the patients' tolerability.
Shuganjieyu capsule adjunctively to lithium therapy, target dose 1440 mg/d.
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
The change of HAM-D total score only for the phase I
Time frame: baseline and 8 weeks
Time to new intervention for an emerging mood episode
Time to new intervention for an emerging mood episode is only for Phase II and Phase III, including drug treatment (commencement of a new drug, increase in dose of concurrent drug, restarting of a discontinued drug, or increasing the investigational drug dose in response to an emergent mood episode) or admission to hospital.
Time frame: up to 48 weeks
HAM-D total score ≤7
Remission rate
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in HAM-D total score ≥50%
Response rate
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in 16-item Quick Inventory of Depressive Symptomatology-Patient Self-Report (QIDS16-SR)
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in Clinical Global Impression scale of Bipolar Disorder-Severity (CGI-BP-S)
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in Sheehan Disability Scale (SDS)
Social function
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III
Mean changes from baseline to EOS in 6-item Quality of Life scale (QOL-6)
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Social function
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III
Young Mania Rating Scale (YMRS) total score ≤10
Using YMRS total score to monitor the switching from depression to hypomania and mania
Time frame: 8 weeks for phase I, up to 48 weeks for phase II and III