Acute Treatment of Bipolar II Depression | NCT00074776

Studies
Acute Treatment of Bipolar II Depression

NCT00074776

Sponsor

Stanford University

Status

Completed

Last Update Posted

Jul 23, 2012Estimated

Enrollment

102Actual

Phase

Phase 3

Conditions

Bipolar Disorder

Interventions

Lithium
Lamotrigine

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

ID	Type	Description	Link
R21MH067055	U.S. NIH Grant/Contract		View source
DSIR 83-ATSO

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Dec 19, 2003

First Submission Date that Met QC Criteria

Dec 19, 2003

First Posted Date

Dec 22, 2003Estimated

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

Jul 19, 2012

Last Update Posted Date

Jul 23, 2012Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study will compare the medications lithium and lamotrigine (Lamictal®) in treating depression in individuals with bipolar II disorder.

Detailed Description

Bipolar II disorder (BDII) is a serious condition characterized by depressive and hypomanic episodes. The disability and suicide risk associated with BDII is equal to bipolar I disorder. However, there are no clinical trials for BDII, nor is the treatment of BDII addressed in current treatment guidelines. Data suggest that Li and LTG may be effective treatment options for BDII. This study will determine the safety, effectiveness, and tolerability of the two drugs in people with BDII.

Participants in this study will be randomly assigned to receive either Li or LTG for 16 weeks. Participants will be assessed every 2 weeks. One week after study completion, participants will have a follow-up visit. Measures of depression, mania, quality of life, functioning, and participant satisfaction will be taken.

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

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 Lithium	Experimental		Drug: Lithium
2 Lamotrigine	Experimental		Drug: Lamotrigine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lithium	Drug	Participants will receive lithium.	1 Lithium
Lamotrigine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression		Measured at baseline and Week 16

Secondary Outcomes

Measure	Description	Time Frame
Incidence and severity of hypomanic and depressive symptoms		Measured at baseline and Week 16
Medication tolerability, response (defined as a 50% reduction on the Ham-D), and remission (defined as Ham-D or MADRS score less than 12)		Measured at baseline and Week 16

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Current diagnosis of bipolar II disorder

Exclusion Criteria:

Use of lithium or lamotrigine
Intolerance to lithium or lamotrigine
Substance abuse or dependence within the last month
Suicidal thoughts
Unstable medical conditions
Pregnancy or breast-feeding
Stable on current medications
Use of fluoxetine (Prozac) within 2 weeks of study
Require an antipsychotic medication
Do not speak or read English

Accepts Healthy Volunteers

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

Name	Affiliation	Role
Trisha Suppes, MD, PhD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Southwestern Medical Center at Dallas		Dallas	Texas	75390-9121	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18358540	Result	Suppes T, Marangell LB, Bernstein IH, Kelly DI, Fischer EG, Zboyan HA, Snow DE, Martinez M, Al Jurdi R, Shivakumar G, Sureddi S, Gonzalez R. A single blind comparison of lithium and lamotrigine for the treatment of bipolar II depression. J Affect Disord. 2008 Dec;111(2-3):334-43. doi: 10.1016/j.jad.2008.02.004. Epub 2008 Mar 20.

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

ID	Term
D008672	Metals, Alkali
D004602	Elements
D007287	Inorganic Chemicals
D019565	Metals, Light