Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)

Tadashi Hasegawa

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder

Treatments: Drug: olanzapine; Drug: lithium

Study type: Interventional

Funder types: Other

Identifiers

NCT02287259

ChibaU

Details and patient eligibility

About

Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point)
• 18years to 65years
• subjects who sign the informed consent document

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Olanzapine

Experimental group

Description:

PO start with 2.5mg daily once for 7days, since then flexible dose.

Treatment:

Drug: olanzapine

Lithium

Active Comparator group

Description:

PO start with 400mg daily twice for 7days, since then flexible dose.

Treatment:

Drug: lithium