Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183443
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2005-09-13
Brief Title:
Treatment of Mania Symptoms With Drug Therapy
Sponsor:
Palo Alto Veterans Institute for Research
Organization:
Palo Alto Veterans Institute for Research
Study Overview
Official Title:
Divalproex Extended Release and Placebo Lithium or Quetiapine for Mania
Status:
COMPLETED
Status Verified Date:
2018-06
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 determine the effectiveness of three different drug therapies in treating the symptoms of mania
Detailed Description:
Mania is a serious condition characterized by extreme excitement mental and physical hyperactivity insomnia and disconnected thoughts Symptoms of mania are common in patients with schizophrenia or bipolar disorder When associated with these conditions mania reaches psychotic proportions and often includes hallucinations paranoia and feelings of omnipotence Such symptoms may put individuals with mania and those around them at risk for physical harm Drug therapies that can safely and effectively treat symptoms of mania are needed This study will compare three drug combinations in their ability to treat symptoms of mania in people with schizophrenia or bipolar I disorder
This study will comprise a 12-week acute phase and a 14-week continuation phase While the acute phase is the primary component of this study the continuation phase will provide extended data on the characteristics and course of responders to the initial treatment combinations Results from the continuation phase will be reported elsewhere In the acute phase participants will be randomly assigned to receive one of three treatments divalproex-extended release DV-ER and lithium DV-ER and quetiapine or DV-ER and placebo Participants will receive their intervention for 12 weeks Participants will have weekly study visits for the first 4 weeks of the acute phase biweekly study visits will occur for the following 8 weeks After the acute phase participants who have not responded to their drug regimen will complete their participation in the study
Participants whose symptoms of mania have decreased will be offered enrollment in the 14-week continuation phase during which time participants will continue the drug regimen they began in the acute phase Participants will have biweekly study visits in the continuation phase During each study visit in both phases participants will be interviewed about their mania symptoms Mania depression quality of life and overall functioning scales will assess participants at study entry at the end of the acute phase and at the end of the continuation phase Participants over 50 years of age will have an electrocardiogram EKG at study entry to determine cardiac function
This study will comprise a 12-week acute phase and a 14-week continuation phase While the acute phase is the primary component of this study the continuation phase will provide extended data on the characteristics and course of responders to the initial treatment combinations Results from the continuation phase will be reported elsewhere In the acute phase participants will be randomly assigned to receive one of three treatments divalproex-extended release DV-ER and lithium DV-ER and quetiapine or DV-ER and placebo Participants will receive their intervention for 12 weeks Participants will have weekly study visits for the first 4 weeks of the acute phase biweekly study visits will occur for the following 8 weeks After the acute phase participants who have not responded to their drug regimen will complete their participation in the study
Participants whose symptoms of mania have decreased will be offered enrollment in the 14-week continuation phase during which time participants will continue the drug regimen they began in the acute phase Participants will have biweekly study visits in the continuation phase During each study visit in both phases participants will be interviewed about their mania symptoms Mania depression quality of life and overall functioning scales will assess participants at study entry at the end of the acute phase and at the end of the continuation phase Participants over 50 years of age will have an electrocardiogram EKG at study entry to determine cardiac function
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR 83-ATSO | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH069801 |
| R01MH069801 | NIH | None | None |