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Algorithm Guided Treatment Strategies for Bipolar Depression (AGTs-BD)

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ClinicalTrials.gov Identifier: NCT01938859
Recruitment Status : Active, not recruiting
First Posted : September 10, 2013
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Yiru FANG M.D., Ph.D., 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Lithium Drug: Quetiapine Drug: Shuganjieyu capsule Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Algorithm Guided Treatment Strategies for Bipolar Depression
Actual Study Start Date : June 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Lithium combined with SGAs
SGAs (Second Generation Antipsychotics), quetiapine adjunctive to lithium therapy
Drug: Lithium
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.

Drug: Quetiapine
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.

Experimental: lithium combined with TCM
TCM (Traditional Chinese Medicine), Shuganjieyu capsule adjunctive to lithium therapy.
Drug: Lithium
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.

Drug: Shuganjieyu capsule
Shuganjieyu capsule adjunctively to lithium therapy, target dose 1440 mg/d.
Other Name: SGJY, St.John's wort and acanthopanax senticosus combination

Active Comparator: Lithium monotherpy
Lithium monotherapy
Drug: Lithium
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.




Primary Outcome Measures :
  1. The change of HAM-D total score only for the phase I [ Time Frame: baseline and 8 weeks ]
  2. Time to new intervention for an emerging mood episode [ Time Frame: 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 :
  1. HAM-D total score ≤7 [ Time Frame: 8 weeks for phase I, up to 48 weeks for phase II and III ]
    Remission rate

  2. Mean changes from baseline to EOS in HAM-D total score ≥50% [ Time Frame: 8 weeks for phase I, up to 48 weeks for phase II and III ]
    Response rate

  3. 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 ]
  4. 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 ]
  5. Mean changes from baseline to EOS in Sheehan Disability Scale (SDS) [ Time Frame: 8 weeks for phase I, up to 48 weeks for phase II and III ]
    Social function

  6. Mean changes from baseline to EOS in 6-item Quality of Life scale (QOL-6) [ Time Frame: 8 weeks for phase I, up to 48 weeks for phase II and III ]
    Social function

  7. Young Mania Rating Scale (YMRS) total score ≤10 [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938859


Locations
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China, Shanghai
Shanghai Mental Health Center
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
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Principal Investigator: Yiru Fang, M.D., Ph.D. Shanghai Mental Health Center

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Responsible Party: Yiru FANG M.D., Ph.D., M.D., Ph.D., Professor of Psychiatry, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT01938859     History of Changes
Other Study ID Numbers: 2012BAI01B04-BD
2012BAI01B04 ( Other Grant/Funding Number: 2012BAI01B04 )
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

Keywords provided by Yiru FANG M.D., Ph.D., Shanghai Mental Health Center:
bipolar disorder
lithium
quetiapine
Medicine, Chinese Traditional
efficacy
safety
Recurrence

Additional relevant MeSH terms:
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Depression
Bipolar Disorder
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Quetiapine Fumarate
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents