Olanzapine-valproate combination versus olanzapine or valproate monotherapy in the treatment of bipolar manic episodes: a randomized, controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13003554

Enrollment

Unknown

Registered

2013-08-17

Start date

2009-04-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

bipolar I disorder mania-episode

Interventions

A:Taking valproate

B:Taking olanzapine

C:Taking olanzapine and valproate

Eligibility

Sex/Gender

All

Age

19 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Meet DSM-IV diagnostic criteria for bipolar I disorder; 2. Current manifestations of acute manic episodes (with or without psychotic symptoms); 3. Aged 18 to 65 years of outpatient or inpatient; 4. Y-MRS total score >=20.

Exclusion criteria

Exclusion criteria: 1. Female patients with pregnant or lactating; 2. Severe and unstable physical illness, including: cardiovascular, respiratory, liver, kidney, gastrointestinal, neurological, endocrine, immune, blood system, narrow-angle glaucoma, history of seizures; 3. Meet DSM-IV substance dependence (except tobacco) standards; 4. History of unable to tolerate olanzapine or valproate; 5. History of long-acting antipsychotic injection, or used other antipsychotics or mood stabilizers before including the study.

Design outcomes

Primary

Measure	Time frame
Y-MR;	—

Secondary

Measure	Time frame
CGI-S-B;	—

Countries

China

Contacts

Public ContactZhen Lin

linzzr@126.com+86 13606509130

Outcome results

None listed

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