A randomized, open label trial of olanzapine versus lithium in the treatment of acute depression in patients with bipolar II or bipolar not otherwise specified.

A randomized, open label trial of olanzapine versus lithium in the treatment of acute depression in patients with bipolar II or bipolar not otherwise specified. - OL study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015124

Enrollment

236

Registered

2014-09-11

Start date

2014-10-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Bipolar II disorder or Bipolar disorder not otherwise specified(NOS)

Interventions

Olanzapine group:starting dose 2.5mg daily once. flexible dose trial. Lithium group:starting dose 400mg daily twice. flexible dose trial.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)major depressive episode in type2 bipolar disorder or 2)bipolar disorder NOS.(MADRS more than 20 point). 3)18years to 65years. 4)subjects who sign the informed consent document.

Exclusion criteria

Exclusion criteria: 1)don't have Diabetes and abnormal metabolism of sugar 2)not noticed as bipolar disorder. 3)have an organic brain disease. 4)pregnant or breastfeeding women. 5)don't have heart disease. 6)have actively suicidal thought(Suicidal ideation score of MADRS is 6). 7)who are judged by the investigator to should be excluded from the study.

Design outcomes

Primary

Measure	Time frame
The primary study endpoint is change in MADRS total score between baseline and 8 weeks.	—

Secondary

Measure	Time frame
YMARS(Young Mania Rating Scale) QIDS-J(Quick Inventory of Depressive Symptomatology Japanese version) STAI(State Trait Anxiety Inventory Form JYZ) TEMPS-A(Temperament Evaluation of Memphis, Pisa, Paris and San Diego) BSDS(Bipolar Spectrum Diagnostic Scale) CGI-BP(Clinical Global Impression for Bipolar Disorder) Bipolarity index Side effects	—

Countries

Japan

Contacts

Public ContactTadashi Hasegawa

Chiba University Hospital Department of psychiatry

t0715.hasegawa@gmail.com043-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026