Efficacy and Safety of SPD417 in Treatment of Manic Sympt... | NCT00150553

Studies
Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder

NCT00150553

Sponsor

Validus Pharmaceuticals

Status

Completed

Last Update Posted

Nov 2, 2007Estimated

Enrollment

102

Phase

Phase 3

Conditions

Bipolar Disorder

Interventions

Extended-release carbamazepine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Oct 2005

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 6, 2005

First Posted Date

Sep 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2007

Last Update Posted Date

Nov 2, 2007Estimated

Description Module

Brief Summary

The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102

Name	Type	Description	Arm Group Labels	Other Names
Extended-release carbamazepine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Score on Young Mania Rating Scale (YMRS) at 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to remission
Clinical Global Impressions Scale - Bipolar Version
HAM-D and MADRS scales for depression

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DSM-IV criteria for bipolar I disorder
Screen YMRS score => 16
Women of childbearing potential agree to take adequate precautions against contraception

Exclusion Criteria:

Hospitalization required for treatment of psychiatric symptoms
Patients who meet DSM-IV for ultra-rapid cycling
History of serious suicide attempt requiring medical intervention

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided