Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression | NCT01131559

Studies
Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

NCT01131559

Sponsor

Lindner Center of HOPE

Status

Terminated

Last Update Posted

Mar 5, 2014Estimated

Enrollment

50Estimated

Phase

Phase 3

Conditions

Bipolar
Depression

Interventions

Lisdexamfetamine
Placebo control

Countries

United States

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

Mar 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor halted study.

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Mar 19, 2010

First Submission Date that Met QC Criteria

May 26, 2010

First Posted Date

May 27, 2010Estimated

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

Mar 4, 2014

Last Update Posted Date

Mar 5, 2014Estimated

Name	Class
Shire	INDUSTRY
University of Cincinnati	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar disorder.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lisdexamfetamine	Active Comparator	Drug	Drug: Lisdexamfetamine
Placebo	Placebo Comparator	Drug	Drug: Placebo control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lisdexamfetamine	Drug	Oral; 20-70mg/day	Lisdexamfetamine	Vyvanse

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in MADRS score	The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score.	30-36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects will meet DSM-IV-TR criteria bipolar I or II disorder,

Exclusion Criteria:

Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.
Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lindner Center of HOPE		Mason	Ohio	45040	United States

Label	URL
Link to facility where study is conducted	View source

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069478	Lisdexamfetamine Dimesylate

Ancestor Terms

ID	Term
D003913	Dextroamphetamine
D000661	Amphetamine
D000662	Amphetamines
D010627	Phenethylamines

Browse Leaves

Not provided

Browse Branches

Not provided