Bipolar II DisorderPhase 4NCT00237666
Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression
A Phase 4 study testing Ziprasidone in people with Bipolar II Disorder and Major Depressive Episode, run by The Medical Research Network at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a major depressive episode. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar II Disorder, Major Depressive Episode
- What is being tested?
- Ziprasidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2005to Feb 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients will meet DSM-IV criteria for Bipolar II Disorder, with at least one hypomanic episode as documented in the medical history or provided by an informant, or have evidence of a clear diagnosis of hypomania
- patients will currently be experiencing a major depressive episode of 2 or more weeks, but less than 12 months duration
- minimum score of 18 on the 17-item HAM-D at screen and baseline
Who cannot join
- patients will not meet criteria for Bipolar I or Schizoaffective Disorder or Schizophrenia
- patients may have co-morbid anxiety or other Axis I disorders as long as depression dominates the clinical picture
- Suicidal ideation or history that makes participation in a clinical trial unduly risky
- unstable medical conditions or any abnormality in thyroid function
- patients with a QTc of 450msec or greater on the initial ECG
- patients requiring concomitant psychotropic drugs will not be eligible, although patients on such drugs who can undergo washout will be eligible. such patients must have discontinued psychoactive drugs at least 2 weeks before beginning study, with 4 weeks for fluoxetine and depot neuroleptics
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- the use of Zolpidem 5-10 mg as needed will be permitted for patients suffering from insomnia, but cannot be taken the night before a scheduled assessment
- patients with dementia or substance abuse in the last 6 months
- pregnant or lactating women will be excluded, as will those not using adequate forms of contraception
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical Research Network, L.L.C.
New York, New York, 10024
The Mech Center
Plano, Texas, 75024
About this study
Official title: An Open-Label, Flexible-Dose Trial of the Safety and Efficacy of Geodon in Non-Rapid-Cycling Bipolar II Patients With Major Depression
The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a major depressive episode.
Read the detailed description
Bipolar II disorder is largely unstudied, with much less known about its treatment in comparison to Bipolar I disorder. While established mood stabilizers treat and prevent subsequent episodes of hypomania, chronic or recurrent depressions are harder to treat or prevent. In general the treatment of depression in Bipolar II patients is often complicated and there is no clinical unanimity on what approaches to follow. Administration of proven antidepressants would seem most appropriate and are most often used, but their use often involves a number of difficulties. Among these are:
- antidepressant efficacy is established for unipolar patients and extrapolation to Bipolar II patients is done without empirical support
- Bipolar II patients can have switches into hypomanic behavior in response to antidepressant treatment given as monotherapy
- even when mood stabilizers are concomitantly given, switches to hypomanic states still occur when antidepressants are added
- antidepressants can cause cycle acceleration or induce rapid cycling when given to Bipolar II patients
- non-response and loss of response are common reactions to antidepressants in Bipolar II patients
This study will also assess the tolerability of Geodon in the treatment of patients diagnosed with Bipolar II disorder who currently meet criteria for a Major Depressive Episode by examining the incidence of adverse events and the withdrawal rate due to adverse events.
This will be an open-label study. Subjects will be treated for 8 weeks with Geodon, starting at a dose of 20 mg twice per day. The maximum dose will be 60 mg twice per day. Subjects will have a physical exam, electrocardiogram (ECG), standard laboratory tests and a urine drug screen at the screen visit.
Efficacy evaluations will include 17-item Hamilton Depression Scale, Hamilton Anxiety Scale (HAM-D), Montgomery-Asberg Depression Rating Scale, and the Young Mania Rating Scale. Social outcome will be measured with a quality-of-life scale (the Q-LES-Q). Overall efficacy will be rated using the Clinical Global Severity and Improvement Scales.
- Conditions
- Bipolar II Disorder, Major Depressive Episode
- Being tested
- Ziprasidone
- Keywords
- Bipolar II Disorder, Major Depressive Episode
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZiprasidoneDrug
Also called Geodon
Ziprasidone 20-60 mg BID, taken orally.
| Study group | Role | What they receive |
|---|---|---|
| Ziprasidone | Experimental | Ziprasidone monotherapy, 20-60 mg BID. Receives: Drug: Ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores
Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms.
Measured: Week 8
Secondary outcomes (6)
Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)
Hamilton Anxiety Rating Scale, measuring anxiety symptoms; possible total scores ranging from 0-30, with higher scores indicating greater severity of anxiety.
Measured: Week 8
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale
Montgomery-Åsberg Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-60, with higher scores indicating greater severity of depression.
Measured: Week 8
Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2
Clinical Global Impression of Improvement scale: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement.
18 subjects (60%) were responders (defined as having a CGI-I scores of 1 or 2 at Week 8/study endpoint) by the end of the trial.
Measured: Week 8
Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint
Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness.
Measured: Week 8
Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale consists of 14 items; possible scores range from 14-70 with higher scores indicating greater quality of life and satisfaction.
Measured: Week 8
Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI)
Beck Depression Inventory, self-rated scale measuring depression symptoms; possible total scores ranging from 0-63, with higher scores indicating greater severity of depression.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startFeb 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar II 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medical Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Liebowitz, Michael R., M.D., Pfizer
- Responsible party
- Sponsor
- Investigators
- Michael R Liebowitz, MD, Principal investigator, Medical Research Network, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237666
- Sponsor's protocol ID
- 04-3945-A 01
- Status last verified
- May 2013
- First submitted
- 7 Oct 2005
- Last updated
- 19 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Flexible-Dose Trial of the Safety and Efficacy of Geodon in Non-Rapid-Cycling Bipolar II Patients With Major Depression
- ClinicalTrials.gov ID
- NCT00237666
- Acronym / sponsor ID
- 04-3945-A 01
- Conditions
- Bipolar II Disorder, Major Depressive Episode
- Keywords
- Bipolar II Disorder, Major Depressive Episode
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Medical Research NetworkUniversity, hospital or other
- Collaborators
- Liebowitz, Michael R., M.D., Pfizer
- Study start
- Feb 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Posted 19 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a major depressive episode.
Detailed description
Bipolar II disorder is largely unstudied, with much less known about its treatment in comparison to Bipolar I disorder. While established mood stabilizers treat and prevent subsequent episodes of hypomania, chronic or recurrent depressions are harder to treat or prevent. In general the treatment of depression in Bipolar II patients is often complicated and there is no clinical unanimity on what approaches to follow. Administration of proven antidepressants would seem most appropriate and are most often used, but their use often involves a number of difficulties. Among these are:
- antidepressant efficacy is established for unipolar patients and extrapolation to Bipolar II patients is done without empirical support
- Bipolar II patients can have switches into hypomanic behavior in response to antidepressant treatment given as monotherapy
- even when mood stabilizers are concomitantly given, switches to hypomanic states still occur when antidepressants are added
- antidepressants can cause cycle acceleration or induce rapid cycling when given to Bipolar II patients
- non-response and loss of response are common reactions to antidepressants in Bipolar II patients
This study will also assess the tolerability of Geodon in the treatment of patients diagnosed with Bipolar II disorder who currently meet criteria for a Major Depressive Episode by examining the incidence of adverse events and the withdrawal rate due to adverse events.
This will be an open-label study. Subjects will be treated for 8 weeks with Geodon, starting at a dose of 20 mg twice per day. The maximum dose will be 60 mg twice per day. Subjects will have a physical exam, electrocardiogram (ECG), standard laboratory tests and a urine drug screen at the screen visit.
Efficacy evaluations will include 17-item Hamilton Depression Scale, Hamilton Anxiety Scale (HAM-D), Montgomery-Asberg Depression Rating Scale, and the Young Mania Rating Scale. Social outcome will be measured with a quality-of-life scale (the Q-LES-Q). Overall efficacy will be rated using the Clinical Global Severity and Improvement Scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ziprasidone | Experimental | Drug: ZiprasidoneZiprasidone monotherapy, 20-60 mg BID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients will meet DSM-IV criteria for Bipolar II Disorder, with at least one hypomanic episode as documented in the medical history or provided by an informant, or have evidence of a clear diagnosis of hypomania
- patients will currently be experiencing a major depressive episode of 2 or more weeks, but less than 12 months duration
- minimum score of 18 on the 17-item HAM-D at screen and baseline
Key exclusion criteria (9 listed)
- patients will not meet criteria for Bipolar I or Schizoaffective Disorder or Schizophrenia
- patients may have co-morbid anxiety or other Axis I disorders as long as depression dominates the clinical picture
- Suicidal ideation or history that makes participation in a clinical trial unduly risky
- unstable medical conditions or any abnormality in thyroid function
- patients with a QTc of 450msec or greater on the initial ECG
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 |
|---|---|---|
| ZiprasidoneAlso: GeodonZiprasidone 20-60 mg BID, taken orally. | Drug | Ziprasidone |
Primary outcome
The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores
Time frame: Week 8
Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms.
6 secondary outcomes
Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)
Time frame: Week 8
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale
Time frame: Week 8
Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2
Time frame: Week 8
Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint
Time frame: Week 8
Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time frame: Week 8
Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI)
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study Site InformationLink provided by the sponsor.
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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.
Michael R Liebowitz, MD principal investigator
Medical Research Network, L.L.C.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ziprasidone in people with Bipolar II Disorder and Major Depressive Episode, run by The Medical Research Network at 2 sites in United States.
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 9 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 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 19 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores (time frame: Week 8). 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 19 Jun 2013.