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

• Sponsor: Tadashi Hasegawa (Other)
• Overall Status: Completed
• CT.gov ID: NCT02287259
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 52.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: olanzapine; Drug: lithium	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Mar 31, 2019
• Actual Study Completion Date: Mar 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olanzapine PO start with 2.5mg daily once for 7days, since then flexible dose.	Drug: olanzapine
Active Comparator: Lithium PO start with 400mg daily twice for 7days, since then flexible dose.	Drug: lithium

Outcome Measures

Primary Outcome Measures

1. Change in Montgomery- Åsberg Depression Rating(MADRS) [Baseline and 8 weeks]

Secondary Outcome Measures

1. Change in Young Mania Rating Scale(YMARS) [Baseline and 8 weeks]

2. Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J) [Baseline and 8 weeks]

3. State Trait Anxiety Inventory Form JYZ(STAI) [Baseline and 8 weeks]

4. Clinical Global Impression for Bipolar Disorder(CGI-BP) [Baseline and 8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chiba University Hospital	Chiba-shi		Japan

Sponsors and Collaborators

• Tadashi Hasegawa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tadashi Hasegawa, medical doctor(assistant professor), Chiba University
• ClinicalTrials.gov Identifier: NCT02287259
• Other Study ID Numbers: ChibaU
• First Posted: Nov 10, 2014
• Last Update Posted: Dec 5, 2019
• Last Verified: Dec 1, 2019

• Additional relevant MeSH terms: Bipolar Disorder; Olanzapine

Study Results

No Results Posted as of Dec 5, 2019