Algorithm Guided Treatment Strategies for Bipolar Depression

NCT01938859 | Unknown Phase 4

• 2 other identifiers: 2012BAI01B04-BD2012BAI01B04
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

bipolar disorder; lithium; quetiapine; Medicine, Chinese Traditional; efficacy; safety; Recurrence

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  up to 48 weeks

Secondary Outcomes (7)

• HAM-D total score ≤7

  8 weeks for phase I, up to 48 weeks for phase II and III

• 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

• 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

Study Arms (3)

Lithium combined with SGAs

EXPERIMENTAL

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

Drug: Lithium; Drug: Quetiapine

lithium combined with TCM

EXPERIMENTAL

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

Drug: Lithium; Drug: Shuganjieyu capsule

Lithium monotherpy

ACTIVE COMPARATOR

Lithium monotherapy

Drug: Lithium

Interventions

Lithium 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.

Lithium combined with SGAs; Lithium monotherpy; lithium combined with TCM

Quetiapine 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 SGAs

Shuganjieyu capsule DRUG

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

Also known as: SGJY, St.John's wort and acanthopanax senticosus combination

lithium combined with TCM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Bipolar Disorder; Recurrence

Interventions

Lithium; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yiru Fang, M.D., Ph.D.

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., Professor of Psychiatry

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 10, 2013
• Study Start: June 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: October 5, 2017

Record last verified: 2017-10

Locations

CN (1)