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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00563992
First received: November 23, 2007
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Bipolar Disorder
Drug: Lithium
Drug: Valproic acid
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacotherapy of High-Risk Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Severity of depression and mania by SADS-C (Schedule for Affective Disorders and Schizophrenia, Change) and LIFE (Longitudinal Interval Follow-up Evaluation) [ Time Frame: Measured between Months 2 and 6 and at Month 12 ] [ Designated as safety issue: No ]
  • Suicide history form and Scale for Suicidal Ideation [ Time Frame: Measured between Months 2 and 6 and at Month 12 ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: January 2001
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will take lithium for 12 months
Drug: Lithium
Participants may also be required to take the antidepressant paroxetine and/or the medication olanzapine for a portion of the study.
Experimental: 2
Participants will take valproate for 12 months
Drug: Valproic acid
Participants may also be required to take the antidepressant paroxetine and/or the medication olanzapine for a portion of the study.
Other Name: Sodium valproate or valproic acid (Depakote)

Detailed Description:

Bipolar disorder, also called manic-depressive illness, is a brain disorder that causes dramatic changes in a person's mood and energy. Bipolar disorder normally forms in late adolescence or early adulthood and requires treatment for the rest of a person's life. People with bipolar disorder undergo periods of extreme happiness and extreme sadness, known as episodes of mania and depression. Symptoms of mania can include increased energy, euphoric moods, mind racing, aggressive behavior, substance abuse, and poor decision making. Symptoms of depression can include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; and inability to concentrate. Some people with bipolar disorder also become suicidal. Suicidal behaviors are more likely to occur at the onset of the illness, making it vital to recognize and treat the disorder early on. Current treatments include mood stabilizing medications and psychotherapy. This study will evaluate the effectiveness of two different mood stabilizing medications, lithium and valproate, in treating people with bipolar disorder and suicidal behavior.

Participants in this double-blind study will be randomly assigned to take one of two medications, either lithium or valproate. In the first 2 to 6 months, depending on clinical condition, participants may also be required to take the antidepressant paroxetine and/or the medication olanzapine. Participants will attend regular visits to a psychiatrist or a psychologist at the Neuroscience Clinic. A blood sample will be taken at each visit to monitor medication blood levels. Participants will also undergo periodic routine laboratory and urine tests to assure their safety.

If the psychiatrist feels improvement has occurred by the end of the 2- to 6-month period, participants will be gradually taken off paroxetine and/or olanzapine over a 2-week period. They will then continue taking the assigned lithium or valproate for the remainder of the study. If the psychiatrist feels the condition has worsened, participants will be prescribed new medications as needed. These medications include other antidepressants (bupropion or venlafaxine) or other antimanic or antipsychotic drugs (perphenazine or haloperidol). Once these participants have achieved at least 2 weeks of normal moods, they will be gradually taken off all other prescribed medications and will remain taking the assigned lithium or valproate. Participants who do not achieve at least 2 weeks of normal moods will stop study participation but will still be offered clinical treatment. The remaining participants taking only lithium or valproate will continue their regular visits with a psychiatrist for the last 6 months of the study. The entire study will last 12 months.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563992

Locations
United States, New York
New York State Psychiatric Institute/Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Maria A. Oquendo, MD Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00563992     History of Changes
Other Study ID Numbers: #4973R, R01MH059710, DSIR 83-ATP
Study First Received: November 23, 2007
Last Updated: April 30, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Valproic Acid
Lithium Carbonate
Lithium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipsychotic Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on July 22, 2014