Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT00277667
Status:
COMPLETED
Last Update Posted:
2009-03-13
First Post:
2006-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Quetiapine Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomanic Symptoms or Mild Manic Symptoms
Sponsor:
Lindner Center of HOPE
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study of Quetiapine Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomanic Symptoms or Mild Manic Symptoms
Status:
COMPLETED
Status Verified Date:
2009-03
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:
The purpose of this research study is to evaluate the safety, tolerability, and efficacy of quetiapine compared to placebo (sugar pill without medication) in the treatment of bipolar disorder with moderate to severe hypomania or mild mania. Quetiapine is approved by the United States Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar mania.
Detailed Description:
Methods and Procedures
This is a single center, eight-week, randomized, double-blind, placebo-controlled, parallel group, flexible-dose study in 40 outpatients with bipolar disorder types I, II, or NOS by DSM-IV-TR criteria who also have moderate-to-severe hypomanic symptoms or mild manic symptoms (defined as a score of \> 3 but \<5 on the Clinical Global Impressions Scale Modified for Bipolar Disorder \[CGI-BP\]). Subjects may have concurrent depressive or anxiety symptoms or syndromes, but they may not have psychotic features (as defined in DSM-IV) or substance dependence. The primary outcome measure will be change in the Young Mania Rating Scale (YMRS) scores. Secondary outcome measures will include the total of the YMRS and the Inventory for Depressive Symptoms (IDS), the IDS alone, the Hamilton Rating Scale for Anxiety (HAM-A), the CGI-BP, the Global Assessment of Functioning (GAF), the Life Functioning Questionnaire (LFQ), and the Sheehan Disability Scale (DSD). Of note, the YMRS-IDS total reflects a novel means of assessing total affective burden. Also, IDS will be used to assess depressive symptoms because of our experience in the Stanley Foundation Bipolar Network indicating that this scale better assesses the signs and symptoms of bipolar depression as compared to both the Hamilton Rating Scale for Depression (HAM-D) and the Montgomery-Asberg Depression Scale (MADRAS). The LFQ is a validated gender neutral scale specifically designed to assess functional outcome in bipolar disorder. The Abnormal Involuntary Movement Scale (AIMS), Simpson Angus Scale (SAS), and Barnes Akathisia Scale (BARS), will be used to assess for degree and severity of extrapyramidal side effects experienced.
Data Analysis and Data Monitoring
All subjects with observations available from the baseline and at least one post-baseline visit will be included in analyses. The primary outcome measure will be the change in YMRS scale scores from baseline to last observation. The difference in YMRS change between treatment groups will be tested for significance (alpha=0.05, two-tailed) using an independent-samples t-test. Measures of change in total affective burden, depressive and anxiety symptoms, global improvement, use of adjunctive anxiolytic and hypnotic medication, adherence to study medication, frequency and severity of side effects, and reasons for early termination will also be analyzed. The final dose achieved by each subject will be correlated with scale score change. Tolerability will be assessed based on adverse experiences, clinical laboratory tests, vital signs (blood pressure and pulse), weight, and discontinuation rates.
This is a single center, eight-week, randomized, double-blind, placebo-controlled, parallel group, flexible-dose study in 40 outpatients with bipolar disorder types I, II, or NOS by DSM-IV-TR criteria who also have moderate-to-severe hypomanic symptoms or mild manic symptoms (defined as a score of \> 3 but \<5 on the Clinical Global Impressions Scale Modified for Bipolar Disorder \[CGI-BP\]). Subjects may have concurrent depressive or anxiety symptoms or syndromes, but they may not have psychotic features (as defined in DSM-IV) or substance dependence. The primary outcome measure will be change in the Young Mania Rating Scale (YMRS) scores. Secondary outcome measures will include the total of the YMRS and the Inventory for Depressive Symptoms (IDS), the IDS alone, the Hamilton Rating Scale for Anxiety (HAM-A), the CGI-BP, the Global Assessment of Functioning (GAF), the Life Functioning Questionnaire (LFQ), and the Sheehan Disability Scale (DSD). Of note, the YMRS-IDS total reflects a novel means of assessing total affective burden. Also, IDS will be used to assess depressive symptoms because of our experience in the Stanley Foundation Bipolar Network indicating that this scale better assesses the signs and symptoms of bipolar depression as compared to both the Hamilton Rating Scale for Depression (HAM-D) and the Montgomery-Asberg Depression Scale (MADRAS). The LFQ is a validated gender neutral scale specifically designed to assess functional outcome in bipolar disorder. The Abnormal Involuntary Movement Scale (AIMS), Simpson Angus Scale (SAS), and Barnes Akathisia Scale (BARS), will be used to assess for degree and severity of extrapyramidal side effects experienced.
Data Analysis and Data Monitoring
All subjects with observations available from the baseline and at least one post-baseline visit will be included in analyses. The primary outcome measure will be the change in YMRS scale scores from baseline to last observation. The difference in YMRS change between treatment groups will be tested for significance (alpha=0.05, two-tailed) using an independent-samples t-test. Measures of change in total affective burden, depressive and anxiety symptoms, global improvement, use of adjunctive anxiolytic and hypnotic medication, adherence to study medication, frequency and severity of side effects, and reasons for early termination will also be analyzed. The final dose achieved by each subject will be correlated with scale score change. Tolerability will be assessed based on adverse experiences, clinical laboratory tests, vital signs (blood pressure and pulse), weight, and discontinuation rates.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: