Algorithm Guided Treatment Strategies for Bipolar Depression
Information source: Shanghai Mental Health Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Lithium (Drug); Quetiapine (Drug); Shuganjieyu capsule (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Shanghai Mental Health Center Official(s) and/or principal investigator(s): Yiru Fang, M.D., Ph.D., Principal Investigator, Affiliation: Shanghai Mental Health Center
Overall contact: Jun Chen, M.D., Ph.D., Phone: (86) 18017311373, Email: doctorcj2010@gmail.com
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.
Clinical Details
Official title: Algorithm Guided Treatment Strategies for Bipolar Depression
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The change of HAM-D total score only for the phase ITime to new intervention for an emerging mood episode
Secondary outcome: HAM-D total score ≤7Mean changes from baseline to EOS in HAM-D total score ≥50% Mean changes from baseline to EOS in 16-item Quick Inventory of Depressive Symptomatology-Patient Self-Report (QIDS16-SR) Mean changes from baseline to EOS in Clinical Global Impression scale of Bipolar Disorder-Severity (CGI-BP-S) Mean changes from baseline to EOS in Sheehan Disability Scale (SDS) Mean changes from baseline to EOS in 6-item Quality of Life scale (QOL-6) Young Mania Rating Scale (YMRS) total score ≤10
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Jun Chen, M.D., Ph.D., Phone: (86) 18017311373, Email: doctorcj2010@gmail.com
Shanghai Mental Health Center, Shanghai, Shanghai 200030, China; Recruiting Jun Chen, M.D., Ph.D., Phone: (86) 18017311373, Email: doctorcj2010@gmail.com Yiru Fang, M.D., Ph.D., Phone: (86) 18017311133, Email: yirufang@gmail.com Yiru Fang, M.D., Ph.D., Principal Investigator Jun Chen, M.D., Ph.D., Sub-Investigator
Additional Information
Starting date: June 2012
Last updated: September 9, 2013
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