Algorithm Guided Treatment Strategies for Bipolar Depression

NCT ID: NCT01938859

Last Updated: 2017-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2018-12-31

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lithium combined with SGAs

SGAs (Second Generation Antipsychotics), quetiapine adjunctive to lithium therapy

Group Type: EXPERIMENTAL

Lithium

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

lithium combined with TCM

TCM (Traditional Chinese Medicine), Shuganjieyu capsule adjunctive to lithium therapy.

Group Type: EXPERIMENTAL

Lithium

Intervention Type: DRUG

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.

Shuganjieyu capsule

Intervention Type: DRUG

Shuganjieyu capsule adjunctively to lithium therapy, target dose 1440 mg/d.

Lithium monotherpy

Lithium monotherapy

Group Type: ACTIVE_COMPARATOR

Lithium

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Shuganjieyu capsule

Shuganjieyu capsule adjunctively to lithium therapy, target dose 1440 mg/d.

Intervention Type: DRUG

Other Intervention Names

SGJY, St.John's wort and acanthopanax senticosus combination

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Yiru FANG M.D., Ph.D.

M.D., Ph.D., Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yiru Fang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

2012BAI01B04

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012BAI01B04-BD

Identifier Type: -

Identifier Source: org_study_id