Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156325
Status:
COMPLETED
Last Update Posted:
2006-01-02
First Post:
2005-09-08
Brief Title:
Escitalopram as a Mood Stabilizer for Bipolar II Disorder
Sponsor:
The University of New South Wales
Organization:
The University of New South Wales
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Trial of Escitalopram as a Mood Stabilizer for Bipolar II Disorder
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the efficacy of Escitalopram a Selective Serotonin Reuptake Inhibitor SSRI antidepressant in the treatment of Bipolar II Disorder
The use of antidepressants for those with bipolar disorder appears common in clinical practice but is not countenanced - at least as monotherapy - in formal treatment guidelines This view reflects concerns about the possibility of antidepressant drugs inducing switching and rapid cycling in those with Bipolar Disorder Although the effectiveness of treating Bipolar II patients with SSRIs has received very little attention in the literature observations of Bipolar II patients treated with SSRIs suggest they may have general mood stabilising properties Many patients have reported improvements not only in their depressed mood but also a reduction in the severity duration and frequency of hypomanic episodes
In this proof of concept study we specifically assess whether a standard dose of an SSRI antidepressant is more effective than placebo in reducing the frequency severity and duration of both depressive and hypomanic episodes
The use of antidepressants for those with bipolar disorder appears common in clinical practice but is not countenanced - at least as monotherapy - in formal treatment guidelines This view reflects concerns about the possibility of antidepressant drugs inducing switching and rapid cycling in those with Bipolar Disorder Although the effectiveness of treating Bipolar II patients with SSRIs has received very little attention in the literature observations of Bipolar II patients treated with SSRIs suggest they may have general mood stabilising properties Many patients have reported improvements not only in their depressed mood but also a reduction in the severity duration and frequency of hypomanic episodes
In this proof of concept study we specifically assess whether a standard dose of an SSRI antidepressant is more effective than placebo in reducing the frequency severity and duration of both depressive and hypomanic episodes
Detailed Description:
This study is a randomized double-blind placebo-controlled cross-over trial of Escitalopram 10 mg versus placebo identical presentation in subjects identified as having Bipolar II Disorder The nine-month study will commence with a no-treatment baseline period of three months Baseline Phase to ensure that subjects meet criteria for episode frequency Subjects compliant with and completing baseline period requirements will then be randomized to receive Escitalopram or placebo for three months Phase 2 and will then subsequently cross over to receive the alternative compound for the final three-month period Phase 3 Prior to that cross-over there will be a two-day taper period to avoid potential withdrawal effects followed by a seven-day wash-out period to avoid carry-over effects from drug to placebo Subjects will be assessed at the start of the study and every month thereafter for the entire nine-month period
Subjects aged 18-65 meeting diagnostic criteria for Bipolar II disorder will be recruited Diagnosis will be based on the Diagnostic and Statistical Manual of Mental Disorders with the exception of the minimum four-day duration criterion for hypomanic episodes Subjects must have a minimum 2-year history of depressive and hypomanic episodes with a mood disturbance either high or low occurring at least monthly Subjects will be excluded if they have previously been treated with anti-depressants or mood-stabilisers or have a history of psychotic symptoms during episodes of either hypomania or depression Subjects who are actively suicidal have a significant personality disorder substantive illicit drug use or alcohol consumption 30gday will also be excluded Exclusion will also apply to subjects who are pregnant or breastfeeding and those with a history of heart disease liver disease epilepsy or seizures
Subjects will complete a number of self-report questionnaires about their mood and functioning on a monthly basis as well as monitoring their mood on a daily basis A research psychologist or psychiatrist will complete at monthly intervals the Hamilton Depression Rating Young Mania Rating Scale and the DSM-IV Social and Occupational Functioning Assessment Scale based on functioning over the previous week throughout the nine-month duration of the study
Subjects aged 18-65 meeting diagnostic criteria for Bipolar II disorder will be recruited Diagnosis will be based on the Diagnostic and Statistical Manual of Mental Disorders with the exception of the minimum four-day duration criterion for hypomanic episodes Subjects must have a minimum 2-year history of depressive and hypomanic episodes with a mood disturbance either high or low occurring at least monthly Subjects will be excluded if they have previously been treated with anti-depressants or mood-stabilisers or have a history of psychotic symptoms during episodes of either hypomania or depression Subjects who are actively suicidal have a significant personality disorder substantive illicit drug use or alcohol consumption 30gday will also be excluded Exclusion will also apply to subjects who are pregnant or breastfeeding and those with a history of heart disease liver disease epilepsy or seizures
Subjects will complete a number of self-report questionnaires about their mood and functioning on a monthly basis as well as monitoring their mood on a daily basis A research psychologist or psychiatrist will complete at monthly intervals the Hamilton Depression Rating Young Mania Rating Scale and the DSM-IV Social and Occupational Functioning Assessment Scale based on functioning over the previous week throughout the nine-month duration of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None