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Combination of antidepressants with mood stabilizers for the maintenance treatment of bipolar depression: a randomized controlled study.

Efficacy and safety of maintenance treatment in patients with bipolar disorder depressive episode

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031256
Enrollment
Unknown
Registered
2020-03-26
Start date
2015-09-25
Completion date
Unknown
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bipolar disorder

Interventions

Group 1:antidepressants combined with mood stabilizers
Group 2:mood stabilizers

Sponsors

Beijing Anding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 62 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria of bipolar I or bipolar II depression in DSM-IV; 2) A major depressive episode occurred within 3 months before enrollment, and the most recent episode was a major depressive episode; 3) Meet clinical remission criteria, defined as HAMD-17 <= 7 points, YMRS <= 7 points, CGI-S <= 2 points for at least 2 weeks; 4) 18-65 years old; 5) Patients voluntarily participated in the study and signed the informed consent by him/herself.

Exclusion criteria

Exclusion criteria: 1) Have been diagnosed of schizophrenia, schizoaffective disorder or other mental disorders associated with diseases; 2) Comorbid personality disorder or mental retardation; 3) Have substance abuse or dependence within 1 year before enrollment; 4) Currently have a serious risk of suicide judged by investigators or HAMD-17 item 3 (suicide item) score >= 3 points; 5) Currently have severe physical illnesses which researchers think it is risky and not eligible to participate; 6) Pregnant or lactating women, or those who are planning to become pregnant, or who do not agree with contraception; 7) Have received electroconvulsive therapy within 1 month before enrollment; 8) Have participated in another interventional clinical study within 1 year before enrollment.

Design outcomes

Primary

MeasureTime frame
Time to recurrence;

Secondary

MeasureTime frame
Assessment of recurrence rate;Assessment of rehospitalization;Pharmacotherapy compliance;Hamilton Depression Rating Score;young manic rating scale;Clinical Global Impression;Globle assessment scale;

Countries

China

Contacts

Public ContactWang Xue

Beijing Anding Hospital, Capital Medical University

xuew37@aliyun.com+86 13466587257

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026