Depression, BipolarPhase 4NCT00835107
An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression
A Phase 4 study testing ziprasidone hydrochloride in people with Depression, Bipolar, run by Queen's University at 1 site in Canada.
Trial summary
This study uses polysomnographs(PSG) to investigate sleep patterns in patients with bipolar depression. This is a double-blind, placebo-controlled, study of ziprasidone that is added to patients current medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Bipolar
- What is being tested?
- ziprasidone hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of Bipolar Disorder Type 1,2 or NOS by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV).
- Current depressive episode with a HAMD-17 of >16.
- Males or Females over age 18yrs.
- Inpatients or outpatients.
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
- Able to understand and comply with the requirements of the study.
- Provision of written informed consent.
Who cannot join
- Current Manic, Hypomanic or Mixed episode, with YMRS > 12.
- Current or past diagnosis of Schizophrenia and Dementia.
- Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing.
- Patient on any other antipsychotic medication.
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
- Known intolerance or lack of response to Ziprasidone, as judged by the investigator.
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- Benzodiazepines and all other sleep-aids must be discontinued prior to participation in the study if they have not been at a stable dosage for the 4 weeks previous to entry into the study.
- No change to the current medication regime (excluding discontinuation of sleep aids and antipsychotic medications) is allowed 4 weeks prior to the first PSG reading.
- Administration of a depot antipsychotic injection within two dosing interval (for the depot) before randomization.
- Substance or alcohol dependence at enrolment or in the last three months (except for caffeine or nicotine dependence), as defined by DSM-IV criteria.
- Serious, unstable or inadequately treated medical illness as judged by the investigator.
- History of epilepsy or uncontrolled seizures.
- Involvement in the planning and conduct of the study.
- Previous enrolment in the present study.
- Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements.
- Patients with serum potassium, magnesium and/or calcium levels outside the normal range at baseline.
- Patients with marked liver function abnormalities at baseline, demonstrated by laboratory values, by judgment of the investigator.
- Known serological evidence of HIV, or acute or chronic hepatitis; donation of blood or blood products for transfusion prior to initiation of the treatment with study drug, during the study and for 30 days after the study has ended.
- Known history of QT prolongation (including congenital long QT syndrome).
- Recent acute myocardial infarction or uncompensated heart failure.
- Currently taking other drugs that are known to prolong the QT interval.
Trial locations and contacts
1 site in 1 country.
About this study
This study uses polysomnographs(PSG) to investigate sleep patterns in patients with bipolar depression. This is a double-blind, placebo-controlled, study of ziprasidone that is added to patients current medications. The objective is to relate changes in slow wave and rapid eye movement sleep to changes in mood and overall illness severity. Participants will be randomly assigned to add either placebo or ziprasidone to their current treatment regimen. Participants make 3 to 4 study visits, over a 1 month period, at which they will be asked about their history, mood and sleep quality. Participants will also have three in-home overnight polysomnographs.
- Conditions
- Depression, Bipolar
- Being tested
- ziprasidone hydrochloride, placebo
- Keywords
- Bipolar Depression, Sleep, Polysomnograph, Slow Wave Sleep, Ziprasidone, Antipsychotic, Placebo
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziprasidone hydrochlorideDrug
Also called Zeldox
oral capsules, from 40-80 mg BID, for one month with the option to continue the medication after the study has been completed
placeboDrug
placebo comparator, oral capsules, BID, for one month
| Study group | Role | What they receive |
|---|---|---|
| Ziprasidone | Experimental | Not described Receives: Drug: ziprasidone hydrochloride |
| Sugar pill | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the objective (polysomnographic) changes in sleep quality before and after introduction of Ziprasidone in treatment of patients with bipolar depression.
Measured: 1 month
Secondary outcomes (1)
To assess the subjective changes in sleep quality parameters before and at different stages after introduction of ziprasidone in treatment, longitudinally, and to correlate these changes with measures of illness severity.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depression, BipolarStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Health & Services, Pfizer, MDS Pharma Services
- Responsible party
- Principal investigator, Dr. Roumen Milev, Queen's University
- Investigators
- Roumen Milev, MD, Principal investigator, Queen's UniversityAnusha Baskaran, BScH, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835107
- Sponsor's protocol ID
- PSIY-287-08
- Other IDs
- GA128250
- Status last verified
- Dec 2015
- First submitted
- 2 Feb 2009
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohrs S, Meier A, Neumann AC, Jordan W, Ruther E, Rodenbeck A. Improved sleep continuity and increased slow wave sleep and REM latency during ziprasidone treatment: a randomized, controlled, crossover trial of 12 healthy male subjects. J Clin Psychiatry. 2005 Aug;66(8):989-96. doi: 10.4088/jcp.v66n0805.
PubMed 16086613Sharpley AL, Cowen PJ. Effect of pharmacologic treatments on the sleep of depressed patients. Biol Psychiatry. 1995 Jan 15;37(2):85-98. doi: 10.1016/0006-3223(94)00135-P.
PubMed 7718684
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression
- ClinicalTrials.gov ID
- NCT00835107
- Acronym / sponsor ID
- PSIY-287-08
- Conditions
- Depression, Bipolar
- Keywords
- Bipolar Depression, Sleep, Polysomnograph, Slow Wave Sleep, Ziprasidone, Antipsychotic, Placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Providence Health & Services, Pfizer, MDS Pharma Services
- Study start
- Feb 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Feb 2009 (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.
This study uses polysomnographs(PSG) to investigate sleep patterns in patients with bipolar depression. This is a double-blind, placebo-controlled, study of ziprasidone that is added to patients current medications. The objective is to relate changes in slow wave and rapid eye movement sleep to changes in mood and overall illness severity. Participants will be randomly assigned to add either placebo or ziprasidone to their current treatment regimen. Participants make 3 to 4 study visits, over a 1 month period, at which they will be asked about their history, mood and sleep quality. Participants will also have three in-home overnight polysomnographs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ziprasidone | Experimental | Drug: ziprasidone hydrochloride |
| Sugar pill | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A diagnosis of Bipolar Disorder Type 1,2 or NOS by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV).
- Current depressive episode with a HAMD-17 of >16.
- Males or Females over age 18yrs.
- Inpatients or outpatients.
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
Key exclusion criteria (21 listed)
- Current Manic, Hypomanic or Mixed episode, with YMRS > 12.
- Current or past diagnosis of Schizophrenia and Dementia.
- Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing.
- Patient on any other antipsychotic medication.
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
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 |
|---|---|---|
| ziprasidone hydrochlorideAlso: Zeldoxoral capsules, from 40-80 mg BID, for one month with the option to continue the medication after the study has been completed | Drug | Ziprasidone |
| placeboplacebo comparator, oral capsules, BID, for one month | Drug | Sugar pill |
Primary outcome
To assess the objective (polysomnographic) changes in sleep quality before and after introduction of Ziprasidone in treatment of patients with bipolar depression.
Time frame: 1 month
1 secondary outcome
To assess the subjective changes in sleep quality parameters before and at different stages after introduction of ziprasidone in treatment, longitudinally, and to correlate these changes with measures of illness severity.
Time frame: 1 month
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 16 Dec 2015.
- Background: PubMed 16086613Cohrs S, Meier A, Neumann AC, Jordan W, Ruther E, Rodenbeck A. Improved sleep continuity and increased slow wave sleep and REM latency during ziprasidone treatment: a randomized, controlled, crossover trial of 12 healthy male subjects. J Clin Psychiatry. 2005 Aug;66(8):989-96. doi: 10.4088/jcp.v66n0805.
- Background: PubMed 7718684Sharpley AL, Cowen PJ. Effect of pharmacologic treatments on the sleep of depressed patients. Biol Psychiatry. 1995 Jan 15;37(2):85-98. doi: 10.1016/0006-3223(94)00135-P.
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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.
Roumen Milev, MD principal investigator
Queen's University
Anusha Baskaran, BScH principal investigator
Queen's 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 ziprasidone hydrochloride in people with Depression, Bipolar, run by Queen's University at 1 site in Canada.
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 7 inclusion and 21 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 16 Dec 2015. 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 Canada. 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?
To assess the objective (polysomnographic) changes in sleep quality before and after introduction of Ziprasidone in treatment of patients with bipolar depression. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00835107, which also lists 2 linked publications.
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 16 Dec 2015.