Bipolar DisorderPhase 4NCT01303601
Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression
A Phase 4 study testing olanzapine and Starch in people with Bipolar Disorder and Depression, Bipolar, run by China Medical University, China at 1 site in China.
Trial summary
Olanzapine may have some antidepressant properties and olanzapine monotherapy has been shown efficacy in bipolar depressive episodes in retrospective studies. However, there has been no prospective study about the monotherapy of olanzapine. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder, Depression, Bipolar
- What is being tested?
- olanzapine and Starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Oct 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Outpatients with clinical diagnosis of bipolarⅠdisorder
- MADRS total score ≥ 20
- CGI-S rating ≥ 4
- Normal results of physical examinations, laboratory and electrocardiogram tests
- Being taken care of by a guardians during the trial
Who cannot join
- Pregnant or lactating women
- YMRS total score ≥ 15
- Treatment with olanzapine within 3 months prior to study entry
- Retrospective history of poor antidepressive response to or intolerance of olanzapine
- Mental retardation
- Addictive disorder
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- Diabetes mellitus
- Dyslipidaemia
- Cardiovascular diseases
- Hypertension
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Psychiatry, the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression: a Randomized, Double-blind, Placebo Controlled Study
Olanzapine may have some antidepressant properties and olanzapine monotherapy has been shown efficacy in bipolar depressive episodes in retrospective studies. However, there has been no prospective study about the monotherapy of olanzapine. The investigators conducted a randomized, placebo-controlled study to test the efficacy of olanzapine monotherapy for treatment of the depressed phase of bipolar disorder.
Read the detailed description
The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention.68 patients were randomized to assigned 6 weeks by olanzapine or placebo. Medications were provided in double-blind fashion. The assessments include Montgomery-Asberg Depression Rating Scale, Young Mania Rating Scale, clinical Global Impressions-Severity of Illness scale, Clinical Global Impressions-Improvement scale, response and remission rates, and Treatment Emergent Symptom Scale.
- Conditions
- Bipolar Disorder, Depression, Bipolar
- Being tested
- olanzapine, Starch
- Keywords
- Olanzapine, Monotherapy, bipolar Ⅰ depression
- 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
Tablet The initial dose of olanzapine was 5mg daily and raised to 10 mg/day. After week 1, flexible dosing was allowed based on symptom response, up to 20 mg daily, as tolerated.
daily 6 weeks
StarchDrug
| Study group | Role | What they receive |
|---|---|---|
| olanzapine | Experimental | Not described Receives: Drug: olanzapine |
| placebo | Placebo comparator | Not described Receives: Drug: Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale
Measured: once weekly
Secondary outcomes (5)
The percentage of participants with a change in MADRS total score ≥50% from baseline as a measure of interventional response
Measured: once
The percentage of participants with an endpoint (last observation available) MADRS total score ≤12 as a measure of interventional remission
Measured: once
Young Mania Rating Scale
Measured: once weekly
Clinical Global Impressions-Severity of Illness Scale
Measured: once weekly
Clinical Global Impressions-Improvement Scale
Measured: once weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startJan 2009
- Study completionOct 2010
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Investigators
- Man Wang, M.D., Study director, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303601
- Sponsor's protocol ID
- MWang
- Status last verified
- Dec 2008
- First submitted
- 24 Feb 2011
- Last updated
- 25 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Olanzapine Monotherapy for Treatment Bipolar Ⅰ Depression: a Randomized, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01303601
- Acronym / sponsor ID
- MWang
- Conditions
- Bipolar Disorder, Depression, Bipolar
- Keywords
- Olanzapine, Monotherapy, bipolar Ⅰ depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- Jan 2009
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Feb 2011 (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.
Olanzapine may have some antidepressant properties and olanzapine monotherapy has been shown efficacy in bipolar depressive episodes in retrospective studies. However, there has been no prospective study about the monotherapy of olanzapine. The investigators conducted a randomized, placebo-controlled study to test the efficacy of olanzapine monotherapy for treatment of the depressed phase of bipolar disorder.
Detailed description
The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention.68 patients were randomized to assigned 6 weeks by olanzapine or placebo. Medications were provided in double-blind fashion. The assessments include Montgomery-Asberg Depression Rating Scale, Young Mania Rating Scale, clinical Global Impressions-Severity of Illness scale, Clinical Global Impressions-Improvement scale, response and remission rates, and Treatment Emergent Symptom Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olanzapine | Experimental | Drug: olanzapine |
| placebo | Placebo comparator | Drug: Starch |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Outpatients with clinical diagnosis of bipolarⅠdisorder
- MADRS total score ≥ 20
- CGI-S rating ≥ 4
- Normal results of physical examinations, laboratory and electrocardiogram tests
- Being taken care of by a guardians during the trial
Key exclusion criteria (10 listed)
- Pregnant or lactating women
- YMRS total score ≥ 15
- Treatment with olanzapine within 3 months prior to study entry
- Retrospective history of poor antidepressive response to or intolerance of olanzapine
- Mental retardation
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 |
|---|---|---|
| olanzapineTablet The initial dose of olanzapine was 5mg daily and raised to 10 mg/day. After week 1, flexible dosing was allowed based on symptom response, up to 20 mg daily, as tolerated. daily 6 weeks | Drug | olanzapine |
| Starch | Drug | placebo |
Primary outcome
Montgomery-Asberg Depression Rating Scale
Time frame: once weekly
5 secondary outcomes
The percentage of participants with a change in MADRS total score ≥50% from baseline as a measure of interventional response
Time frame: once
The percentage of participants with an endpoint (last observation available) MADRS total score ≤12 as a measure of interventional remission
Time frame: once
Young Mania Rating Scale
Time frame: once weekly
Clinical Global Impressions-Severity of Illness Scale
Time frame: once weekly
Clinical Global Impressions-Improvement Scale
Time frame: once weekly
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 25 Feb 2011.
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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.
Man Wang, M.D. study director
First Hospital of China Medical University
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 Starch in people with Bipolar Disorder and Depression, Bipolar, run by China Medical University, China at 1 site in China.
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 5 inclusion and 10 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 25 Feb 2011. 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 China. 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. Some participants in this study may receive a placebo. 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?
Montgomery-Asberg Depression Rating Scale (time frame: once weekly). 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 25 Feb 2011.