Bipolar DisorderNCT01503489
Risk Factors for AD-Associated Switch to Mania
An observational study of Bipolar Disorder, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The present study aimed at identifying clinical risk factors for switch into (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after increasing its dosage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.
- How many people
- 221 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2005to Jul 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bipolar I and II disorder patients.
Who may be able to join
- Bipolar I and II disorder.
Who cannot join
- Major medical comorbidities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk for Antidepressant-associated Switch From Depression to Hypomania, Mania, or Mixed Episode During the 8 Weeks After the Introduction of an Antidepressant or After Increasing the Dosage of Baseline Antidepressant.
The present study aimed at identifying clinical risk factors for switch into (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after increasing its dosage.
Read the detailed description
Treatment of bipolar depression with antidepressants is strongly debated for the methodologically poor and insufficient data supporting their use and the widely held belief that antidepressants can induce new episodes of abnormal mood elevation or accelerate the rate of cycling. The present study aimed at identifying clinical risk factors for switch into (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after increasing its dosage, in a prospective, longitudinal design.
- Conditions
- Bipolar Disorder
- Being tested
- Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.
- Keywords
- Switch
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.Drug
Also called Selective Serotonin Reuptake Inhibitors, Serotonin-Norepinephrine Reuptake Inhibitor, Tricyclics Antidepressants
Risk for antidepressant-associated switch from depression to hypomania, mania, or mixed episode during the 8 weeks after the introduction of an antidepressant or after increasing the dosage of baseline antidepressant.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar depressed patients | Bipolar I or II outpatients, current major depressive episode (HDRS-17 over 20). Receives: Drug: Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk for antidepressant-associated switch from depression to hypomania, mania, or mixed episode during the 8 weeks after the introduction of an antidepressant or after increasing the dosage of baseline antidepressant.
Bipolar I or II outpatients, current major depressive episode (HDRS-17 over 20), were treated with any antidepressant combined with treatment-as-usual, as decided by the treating psychiatrist.
Treatment-emergent affective switch was defined as fully syndromic hypomanic, manic, or mixed episode: YMRS >12 and an increase of 5 points or more compared to the last assessment for hypomanic/manic features, and YMRS and HDRS-17 >14 for a mixed episode.
The above-mentioned alterations needed to occur within 8 weeks after introduction of the antidepressant or after increasing the dosage.
Measured: 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startOct 2005
- Primary completionJan 2010
- Study completionJul 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 Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Eduard Vieta Pascual, MD, Psychiatrist, PhD, Hospital Clinic of Barcelona
- Investigators
- Marc Valenti, MD, Study director, Bipolar Disorders Program, Hospital Clinic Barcelona.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503489
- Sponsor's protocol ID
- SWITCH.
- Status last verified
- Nov 2021
- First submitted
- 29 Dec 2011
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Valenti M, Pacchiarotti I, Undurraga J, Bonnin CM, Popovic D, Goikolea JM, Torrent C, Hidalgo-Mazzei D, Colom F, Vieta E. Risk factors for rapid cycling in bipolar disorder. Bipolar Disord. 2015 Aug;17(5):549-59. doi: 10.1111/bdi.12288. Epub 2015 Feb 12.
PubMed 25682854Valenti M, Pacchiarotti I, Bonnin CM, Rosa AR, Popovic D, Nivoli AM, Goikolea JM, Murru A, Undurraga J, Colom F, Vieta E. Risk factors for antidepressant-related switch to mania. J Clin Psychiatry. 2012 Feb;73(2):e271-6. doi: 10.4088/JCP.11m07166.
PubMed 22401488
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk for Antidepressant-associated Switch From Depression to Hypomania, Mania, or Mixed Episode During the 8 Weeks After the Introduction of an Antidepressant or After Increasing the Dosage of Baseline Antidepressant.
- ClinicalTrials.gov ID
- NCT01503489
- Acronym / sponsor ID
- SWITCH.
- Conditions
- Bipolar Disorder
- Keywords
- Switch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Oct 2005 (actual)
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Jan 2012 (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 present study aimed at identifying clinical risk factors for switch into (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after increasing its dosage.
Detailed description
Treatment of bipolar depression with antidepressants is strongly debated for the methodologically poor and insufficient data supporting their use and the widely held belief that antidepressants can induce new episodes of abnormal mood elevation or accelerate the rate of cycling. The present study aimed at identifying clinical risk factors for switch into (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after increasing its dosage, in a prospective, longitudinal design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bipolar depressed patients | – | Drug: Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.Bipolar I or II outpatients, current major depressive episode (HDRS-17 over 20). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bipolar I and II disorder patients.
Key inclusion criteria (1 listed)
- Bipolar I and II disorder.
Key exclusion criteria (1 listed)
- Major medical comorbidities.
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 |
|---|---|---|
| Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.Also: Selective Serotonin Reuptake Inhibitors, Serotonin-Norepinephrine Reuptake Inhibitor, Tricyclics AntidepressantsRisk for antidepressant-associated switch from depression to hypomania, mania, or mixed episode during the 8 weeks after the introduction of an antidepressant or after increasing the dosage of baseline antidepressant. | Drug | Bipolar depressed patients |
Primary outcome
Risk for antidepressant-associated switch from depression to hypomania, mania, or mixed episode during the 8 weeks after the introduction of an antidepressant or after increasing the dosage of baseline antidepressant.
Time frame: 8 weeks.
Bipolar I or II outpatients, current major depressive episode (HDRS-17 over 20), were treated with any antidepressant combined with treatment-as-usual, as decided by the treating psychiatrist. Treatment-emergent affective switch was defined as fully syndromic hypomanic, manic, or mixed episode: YMRS >12 and an increase of 5 points or more compared to the last assessment for hypomanic/manic features, and YMRS and HDRS-17 >14 for a mixed episode. The above-mentioned alterations needed to occur within 8 weeks after introduction of the antidepressant or after increasing the dosage.
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 29 Nov 2021.
- Derived from this study: PubMed 25682854Valenti M, Pacchiarotti I, Undurraga J, Bonnin CM, Popovic D, Goikolea JM, Torrent C, Hidalgo-Mazzei D, Colom F, Vieta E. Risk factors for rapid cycling in bipolar disorder. Bipolar Disord. 2015 Aug;17(5):549-59. doi: 10.1111/bdi.12288. Epub 2015 Feb 12.
- Derived from this study: PubMed 22401488Valenti M, Pacchiarotti I, Bonnin CM, Rosa AR, Popovic D, Nivoli AM, Goikolea JM, Murru A, Undurraga J, Colom F, Vieta E. Risk factors for antidepressant-related switch to mania. J Clin Psychiatry. 2012 Feb;73(2):e271-6. doi: 10.4088/JCP.11m07166.
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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.
Marc Valenti, MD study director
Bipolar Disorders Program, Hospital Clinic Barcelona.
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 Disorder, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 1 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: finished, as of the sponsor's last update on 29 Nov 2021. 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 Spain. 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?
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?
Risk for antidepressant-associated switch from depression to hypomania, mania, or mixed episode during the 8 weeks after the introduction of an antidepressant or after increasing the dosage of baseline antidepressant. (time frame: 8 weeks.). 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 NCT01503489, 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 29 Nov 2021.