Bipolar disorder- depressive episode
Conditions
Brief summary
Efficacy as determined by response and remission rates: response is defined as a 50% or more reduction of the MADRS score. Remission is defined as a MADRS score that falls under ten.
Detailed description
Safety will be determined by the number of side effects. The potential effect of conversion to mania will be measured by a YMRS of 20 or more points, indicating at least a mild mania. All other psychiatric side effects, such as psychosis and suicidality as well as somatic side effects will be meticulously monitored., Tolarability will be determined by dropout rates during the whole study., Relapse will be monitored and measured by: admission to a psychiatric hospital or ward due to depressive symptoms; a suicide attempt or admission to prevent suicide; an increase in depressive symptoms measured by the MADRS of >25% or above 22 points after initial response or remission following treatment.
Interventions
Sponsors
Academisch Ziekenhuis Leiden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy as determined by response and remission rates: response is defined as a 50% or more reduction of the MADRS score. Remission is defined as a MADRS score that falls under ten. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be determined by the number of side effects. The potential effect of conversion to mania will be measured by a YMRS of 20 or more points, indicating at least a mild mania. All other psychiatric side effects, such as psychosis and suicidality as well as somatic side effects will be meticulously monitored., Tolarability will be determined by dropout rates during the whole study., Relapse will be monitored and measured by: admission to a psychiatric hospital or ward due to depressive symptoms; a suicide attempt or admission to prevent suicide; an increase in depressive symptoms measured by the MADRS of >25% or above 22 points after initial response or remission following treatment. | — |
Countries
Netherlands
Outcome results
None listed