Unique ID issued by UMIN | UMIN000015124 |
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Receipt number | R000017321 |
Scientific 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. |
Date of disclosure of the study information | 2014/09/11 |
Last modified on | 2019/03/28 19:57:59 |
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
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
Japan |
Bipolar II disorder or Bipolar disorder not otherwise specified(NOS)
Psychiatry |
Others
NO
Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
The primary study endpoint is change in MADRS total
score between baseline and 8 weeks.
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Institution is not considered as adjustment factor.
Central registration
2
Treatment
Medicine |
Olanzapine group:starting dose 2.5mg daily once. flexible dose trial.
Lithium group:starting dose 400mg daily twice. flexible dose trial.
18 | years-old | <= |
65 | years-old | >= |
Male and Female
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.
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.
236
1st name | |
Middle name | |
Last name | Masaomi Iyo |
Graduate School of Medicine, Chiba University
Department of psychiatry
1-8-1 Inohana, Chuo-ku, Chiba
0432227171
iyom@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Tadashi Hasegawa |
Chiba University Hospital
Department of psychiatry
1-8-1 Inohana, Chuo-ku, Chiba
043-222-7171
t0715.hasegawa@gmail.com
Chiba University Hospital
Eli Lilly Japan
Profit organization
NO
2014 | Year | 09 | Month | 11 | Day |
Unpublished
Completed
2014 | Year | 08 | Month | 25 | Day |
2014 | Year | 08 | Month | 25 | Day |
2014 | Year | 10 | Month | 01 | Day |
2019 | Year | 02 | Month | 07 | Day |
2019 | Year | 03 | Month | 16 | Day |
2019 | Year | 03 | Month | 28 | Day |
2019 | Year | 03 | Month | 31 | Day |
2014 | Year | 09 | Month | 11 | Day |
2019 | Year | 03 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017321
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