Effectiveness of Lithium and Valproate in Treating High-Risk Bipolar Disorder

NCT00563992 | Completed Phase 1 DMC

• 3 other identifiers: #4973RR01MH059710DSIR 83-ATP
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of two different mood stabilizing medications, lithium and valproate, in treating people with bipolar disorder and suicidal behavior.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

• Severity of depression and mania by SADS-C (Schedule for Affective Disorders and Schizophrenia, Change) and LIFE (Longitudinal Interval Follow-up Evaluation)

  Measured between Months 2 and 6 and at Month 12

• Suicide history form and Scale for Suicidal Ideation

  Measured between Months 2 and 6 and at Month 12

Study Arms (2)

1

EXPERIMENTAL

Participants will take lithium for 12 months

Drug: Lithium

2

EXPERIMENTAL

Participants will take valproate for 12 months

Drug: Valproic acid

Interventions

Lithium DRUG

Participants may also be required to take the antidepressant paroxetine and/or the medication olanzapine for a portion of the study.

1

Valproic acid DRUG

Participants may also be required to take the antidepressant paroxetine and/or the medication olanzapine for a portion of the study.

Also known as: Sodium valproate or valproic acid (Depakote)

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current major depressive episode or mixed episode
• Bipolar disorder
• History of suicidal behavior

You may not qualify if:

• Requires detoxification from alcohol or other substances
• Blood pressure greater than 160/90 mm Hg
• Active medical problems
• Requires long-term antipsychotic maintenance
• Becomes manic on mood stabilizers and antidepressants
• Contraindication to the use of lithium 1 or valproate (including failure to respond)
• Failure to respond to adequate trials of paroxetine, bupropion, and venlafaxine in the 2 years prior to study entry
• Failure to respond to adequate trials of olanzapine, haloperidol, and perphenazine in the 2 years prior to study entry
• Unable or unwilling to consent to treatment
• Pregnant or lactating

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute/Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium; Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Maria A. Oquendo, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2007
• First Posted: November 27, 2007
• Study Start: January 1, 2001
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 1, 2012

Record last verified: 2012-04

Locations

US (1)