Trials / Completed
CompletedNCT01503489
Risk Factors for AD-Associated Switch to Mania
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.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 221 (actual)
- Sponsor
- Hospital Clinic of Barcelona · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics. | 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. |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2010-01-01
- Completion
- 2011-07-01
- First posted
- 2012-01-04
- Last updated
- 2021-11-29
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT01503489. Inclusion in this directory is not an endorsement.