Bipolar DisorderPhase 4NCT02287259
Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)
A Phase 4 study testing olanzapine and lithium in people with Bipolar Disorder, run by Tadashi Hasegawa at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- olanzapine and lithium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2014to 31 Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.
- Conditions
- Bipolar Disorder
- Being tested
- olanzapine, lithium
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
lithiumDrug
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Experimental | PO start with 2.5mg daily once for 7days, since then flexible dose. Receives: Drug: olanzapine |
| Lithium | Active comparator | PO start with 400mg daily twice for 7days, since then flexible dose. Receives: Drug: lithium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery- Åsberg Depression Rating(MADRS)
Measured: Baseline and 8 weeks
Secondary outcomes (4)
Change in Young Mania Rating Scale(YMARS)
Measured: Baseline and 8 weeks
Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J)
Measured: Baseline and 8 weeks
State Trait Anxiety Inventory Form JYZ(STAI)
Measured: Baseline and 8 weeks
Clinical Global Impression for Bipolar Disorder(CGI-BP)
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tadashi Hasegawa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tadashi Hasegawa, Chiba University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287259
- Sponsor's protocol ID
- ChibaU
- Status last verified
- Dec 2019
- First submitted
- 30 Oct 2014
- Last updated
- 5 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02287259
- Acronym / sponsor ID
- ChibaU
- Conditions
- Bipolar Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tadashi HasegawaUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Experimental | Drug: olanzapinePO start with 2.5mg daily once for 7days, since then flexible dose. |
| Lithium | Active comparator | Drug: lithiumPO start with 400mg daily twice for 7days, since then flexible dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olanzapine | Drug | Olanzapine |
| lithium | Drug | Lithium |
Primary outcome
Change in Montgomery- Åsberg Depression Rating(MADRS)
Time frame: Baseline and 8 weeks
4 secondary outcomes
Change in Young Mania Rating Scale(YMARS)
Time frame: Baseline and 8 weeks
Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J)
Time frame: Baseline and 8 weeks
State Trait Anxiety Inventory Form JYZ(STAI)
Time frame: Baseline and 8 weeks
Clinical Global Impression for Bipolar Disorder(CGI-BP)
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing olanzapine and lithium in people with Bipolar Disorder, run by Tadashi Hasegawa at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery- Åsberg Depression Rating(MADRS) (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.