Algorithm Guided Treatment Strategies for Bipolar Depression

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Mental Health Center
• Treatments: Lithium Carbonate; Quetiapine Fumarate

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.