Genetic Predictors of Lithium Response in Bipolar Disorder

NCT00252577 | Completed Results DMC

• 1 other identifier: MHBA-023-05S
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify genetic predictors of lithium response in bipolar disorder.

Conditions

Bipolar Disorder

Keywords

Lithium; Pharmacogenetics

Outcome Measures

Primary Outcomes (1)

• Time to Relapse

  The primary outcome measure was time to relapse in months following stabilization on lithium.

  every 2 months for 2 years

Study Arms (1)

Group 1

Veterans with bipolar disorder

Drug: Lithium treatment

Interventions

Lithium treatment DRUG

Lithium is a standard treatment for bipolar disorder. Patients will be stabilized on lithium monotherapy over a 3 month period, observed for one month, and then followed every 2 months in maintenance phase for 2 years

Group 1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans with bipolar disorder

You may qualify if:

• Are 18 years of age or older;
• Have a diagnosis of Bipolar Affective Disorder, I or II;
• Have no contraindications, allergies, or previous adverse events or treatment failures with lithium;
• Women who are not currently pregnant and are willing and able to use birth control;
• Are clinically appropriate to treat with lithium.

You may not qualify if:

• DSM-IV Axis I Diagnosis: other primary comorbid axis I disorders such as: schizophrenia, schizoaffective disorder, delusional disorder;
• Alcohol or Substance Dependence: meets criteria for dependence within past 3 months;
• Unstable Medial Conditions: Life threatening or unstable medical condition that require active adjustment of medications by medical history; or
• Medical Conditions: concomitant medical condition that would preclude the use of lithium (i.e.: renal failure, head trauma with loss of consciousness, or clinically significant cardiac, renal, hepatic, neoplastic, or cardiovascular disease);
• Concomitant treatment with the following medications (during maintenance Phase): antipsychotics, antidepressants, antianxiety agent with the exception of benzodiazepines, to be used if needed for anxiety or insomnia, not to exceed 10 doses/week, or mood stabilizers with the exception of lithium; and
• Active suicidal or homicidal ideations as elicited in the interviews.
• Stable and doing well on a mood stabilizer other than lithium.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Related Links

• NIMH-sponsored study of the genetics of bipolar disorder
• National Patient support group for bipolar disorder

Biospecimen

Retention: SAMPLES WITH DNA

DNA from patients with bipolar disorder

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Limitations and Caveats

The study results are limited by small sample size and a dropout rate higher than expected.

Results Point of Contact

• Title: John Kelsoe
• Organization: VA San Diego Healthcare System

john.kelsoe@va.gov

858-552-8585

Study Officials

• John R Kelsoe, MD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Study Start: October 1, 2005
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 29, 2020
• Results First Posted: January 29, 2020

Record last verified: 2020-01

Locations

US (1)