Algorithm Guided Treatment Strategies for Bipolar Depression

Phase 4

• Conditions: Bipolar Disorder
• Interventions: Drug: Lithium; Drug: Shuganjieyu capsule; Drug: Quetiapine

• Registration Number: NCT01938859
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-09-05
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-10
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-05
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Age from 18 to 65 years old;
• Han Chinese;
• Outpatient and inpatient patients;
• Patients met DSM-IV criteria of bipolar I or II disorder, currently depressed, ascertained with the Mini International Neuropsychiatric Interview (MINI)
• HAM-D total score≥17, HAM-D item 1 (depressed mood) score≥2, and YMRS total score≤10 at baseline;
• Written informed consent was given;
• Junior high school education and above, with enough audio-visual ability to accomplish the visits;
• Normally resident in one country and had a residential address, able to follow-up.

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Exclusion Criteria

• Bipolar disorder rapid cycling or mixed episode;
• Experienced DSM-IV-TR axis I disorders in the 6 months prior to randomization;
• Severe personality disorder, metal retardation, anorexia/bulimia nervosa;
• Actively suicide ascertained by research psychiatrist or HAM-D item 3 score≥3(suicidality);
• Known history of intolerance or hypersensitivity to any of the medications involved in the study, including lithium, quetiapine and SGJY capsule;
• Female patients who were pregnant, planning to be pregnant or breast feeding;
• Severe medical or neurological problems.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lithium combined with TCM	Lithium	TCM (Traditional Chinese Medicine), Shuganjieyu capsule adjunctive to lithium therapy.
Lithium combined with SGAs	Lithium	SGAs (Second Generation Antipsychotics), quetiapine adjunctive to lithium therapy
Lithium monotherpy	Lithium	Lithium monotherapy
lithium combined with TCM	Shuganjieyu capsule	TCM (Traditional Chinese Medicine), Shuganjieyu capsule adjunctive to lithium therapy.
Lithium combined with SGAs	Quetiapine	SGAs (Second Generation Antipsychotics), quetiapine adjunctive to lithium therapy

Primary Outcome Measures

Name	Time	Method
The change of HAM-D total score only for the phase I	baseline and 8 weeks
Time to new intervention for an emerging mood episode	up to 48 weeks	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.

Secondary Outcome Measures

Name	Time	Method
HAM-D total score ≤7	8 weeks for phase I, up to 48 weeks for phase II and III	Remission rate
Mean changes from baseline to EOS in HAM-D total score ≥50%	8 weeks for phase I, up to 48 weeks for phase II and III	Response rate
Mean changes from baseline to EOS in 16-item Quick Inventory of Depressive Symptomatology-Patient Self-Report (QIDS16-SR)	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)	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)	8 weeks for phase I, up to 48 weeks for phase II and III	Social function
Mean changes from baseline to EOS in 6-item Quality of Life scale (QOL-6)	8 weeks for phase I, up to 48 weeks for phase II and III	Social function
Young Mania Rating Scale (YMRS) total score ≤10	8 weeks for phase I, up to 48 weeks for phase II and III	Using YMRS total score to monitor the switching from depression to hypomania and mania

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China