Bipolar Disease Type ICHAPSNCT00994630
Biomarkers for Bipolar Disorder: Chaperones and Reticulum Endoplasmatic Stress Response CHAP´s Study
An observational study of Bipolar Disease Type I, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine expression of chaperones proteins from the endoplasmatic reticulum stress response system in bipolar I patients (manic phase) compared to healthy controls. Hypothesis: There is no difference in chaperones proteins expression between bipolar I manic patients and healthy controls Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disease Type I
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Aug 2011
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Bipolar Disease type I manic phase
Who may be able to join
- Bipolar Disease type I manic phase
- YMRS > 14
- HDRS < 9
Who cannot join
- Use of lithium, divalproate, or carbamazepine in therapeutic levels over the past 30 days
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Mood Disorders Program, Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo
São Paulo, São Paulo
About this study
The purpose of this study is to determine expression of chaperones proteins from the endoplasmatic reticulum stress response system in bipolar I patients (manic phase) compared to healthy controls.
Hypothesis: There is no difference in chaperones proteins expression between bipolar I manic patients and healthy controls
- Conditions
- Bipolar Disease Type I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BP I patients manic phase | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2011 (estimated)
Why it stopped: fail to get funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disease Type IStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo A Moreno, MD, PhD, Principal investigator, Mood Disorders Program, Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, BrazilMarcio G Soeiro de Souza, MD, Study director, Mood Disorders Program, Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994630
- Sponsor's protocol ID
- CHAPS STUDY
- Acronym
- CHAPS
- Status last verified
- May 2011
- First submitted
- 13 Oct 2009
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Bipolar Disorder: Chaperones and Reticulum Endoplasmatic Stress Response CHAP´s Study
- ClinicalTrials.gov ID
- NCT00994630
- Acronym / sponsor ID
- CHAPS / CHAPS STUDY
- Conditions
- Bipolar Disease Type I
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: fail to get funding
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2011 (estimated)
- First posted
- 14 Oct 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.
The purpose of this study is to determine expression of chaperones proteins from the endoplasmatic reticulum stress response system in bipolar I patients (manic phase) compared to healthy controls.
Hypothesis: There is no difference in chaperones proteins expression between bipolar I manic patients and healthy controls
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BP I patients manic phase | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Bipolar Disease type I manic phase
Key inclusion criteria (3 listed)
- Bipolar Disease type I manic phase
- YMRS > 14
- HDRS < 9
Key exclusion criteria (1 listed)
- Use of lithium, divalproate, or carbamazepine in therapeutic levels over the past 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 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.
Ricardo A Moreno, MD, PhD principal investigator
Mood Disorders Program, Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Brazil
Marcio G Soeiro de Souza, MD study director
Mood Disorders Program, Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disease Type I, run by University of Sao Paulo at 1 site in Brazil.
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 1 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: paused, as of the sponsor's last update on 16 Aug 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 Brazil. 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.
Are results available for this study?
Results are not available in the source record.
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.
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 16 Aug 2011.