Clinical trial NCT01938859: Algorithm Guided Treatment Strategies for Bipolar Depression
Official title: Algorithm Guided Treatment Strategies for Bipolar Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: bipolar disorder
lithium
quetiapine
Medicine, Chinese Traditional
efficacy
safety
Recurrence
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: The change of HAM-D total score only for the phase I
timeFrame: baseline and 8 weeks
measure: Time to new intervention for an emerging mood episode
timeFrame: up to 48 weeks
Secondary outcomes:
measure: HAM-D total score ≤7
timeFrame: 8 weeks for phase I, up to 48 weeks for phase II and III
measure: Mean changes from baseline to EOS in HAM-D total score ≥50%
timeFrame: 8 weeks for phase I, up to 48 weeks for phase II and III
measure: Mean changes from baseline to EOS in 16-item Quick Inventory of Depressive Symptomatology-Patient Self-Report (QIDS16-SR)
timeFrame: 8 weeks for phase I, up to 48 weeks for phase II and III
measure: Mean changes from baseline to EOS in Clinical Global Impression scale of Bipolar Disorder-Severity (CGI-BP-S)
timeFrame: 8 weeks for phase I, up to 48 weeks for phase II and III
measure: Mean changes from baseline to EOS in Sheehan Disability Scale (SDS)
timeFrame: 8 weeks for phase I, up to 48 weeks for phase II and III
measure: Mean changes from baseline to EOS in 6-item Quality of Life scale (QOL-6)
timeFrame: 8 weeks for phase I, up to 48 weeks for phase II and III
measure: Young Mania Rating Scale (YMRS) total score ≤10
timeFrame: 8 weeks for phase I, up to 48 weeks for phase II and III
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Yiru Fang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: