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VALID : VAlproate Versus LIthium in Bipolar Disorders | Clinical Trials | Clareo Health

COMPLETEDPHASE4

VALID : VAlproate Versus LIthium in Bipolar Disorders

A Twelve-Week, Open, Randomized Trial Comparing Valproate to Lithium in Bipolar I Patients Suffering From a Manic Episode

NCT00264173•Sanofi

View on ClinicalTrials.gov

Summary

Primary Objective : * To compare the efficacy of valproate to lithium in Bipolar I patients suffering from a manic or a mixed episode according to DSM IV TR (APA 2000) \[Diagnostic and Statistical Manual of Mental Disorders (DSM) fourth edition (IV)Text Revision (TR)\] and over a periode of 3 weeks and 12 weeks of treatment Secondary Objective : * To evaluate the clinical and biological safety of valproate compared to lithium.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
•Main criteria are listed hereafter:
•Patients with a history of at least one manic episode in the previous three years or before the age of 60 for patients older than 60 at screening, as documented by medical records, or by a relative's report of information corroborating evidence of manic symptomatology for patients already known as bipolar patients. Newly diagnosed patients for bipolar disorder are allowed provided that the diagnosis is based on DSM IV TR\[Diagnostic and Statistical Manual of Mental Disorders (DSM) fourth edition (IV)Text Revision (TR)\]and that the patient is less than 30 years old.
•Patients with a current diagnosis of Bipolar I Disorder according to DSM IV TR
•Patients suffering from a current manic episode or a mixed episode according to DSM IV TR
•Patients with a minimum total score on the Young Mania Rating Scale (YMRS)of 18 at Screening
•Patients having completed the wash-out period of at least 1 day duration (except for patients receiving no psychiatric treatment or a benzodiazepine at a dose lower than the equivalence of 8 mg of lorazepam and except for patients who only received injectable long-acting neuroleptics at least 7 days prior to Screening)
•Patients with a minimum total score on the Young Mania Rating Scale (YMRS) of 18 at D0

Exclusion Criteria

•Participation in a clinical trial within the three previous months
•Patients with a history of valproate intolerance defined as valproate discontinuation due to medically significant adverse effects
•Patients with a history of lithium intolerance defined as lithium discontinuation due to medically significant adverse effects
•Patients with a Central Nervous System (CNS) neoplasm, demyelinating disease, degenerative neurological disorder, active CNS infection or any progressive disorder that may blur interpretation of the study results
•Patients with a history of seizure disorder, cerebrovascular disease, structural brain damage from trauma, clinically significant focal neurological abnormalities, known EEG (Electroencephalography) with frank paroxysmal activity or a known CT scan of the brain demonstrating gross structural abnormalities
•Patients with uncontrolled gastro-intestinal, renal, hepatic, endocrine, cardiovascular, pulmonary, immunological or hematological disease
•Patients with renal insufficiency, cardiac insufficiency and Addison's disease
•Patients with past or current pancreatitis
•Patients with acute hepatitis, chronic hepatitis, or family history of severe hepatitis especially drug related, hepatic porphyry
•Patients with a current DSM IV diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence) or substance abuse with stimulants including but not limited to cocaine, heroin, crack, amphetamines, pseudo-ephedrine, cold medications with phenylephrine or other stimulants. Alcohol or marijuana abuse prior to study entry will be accepted if related to the current manic episode, based on the investigator's judgment
+17 more criteria

Key Dates

Start Date

February 1, 2004

Completion Date

September 1, 2006

Last Updated

November 16, 2007

Enrollment

270

Estimated participants

Conditions

Bipolar Disorder

Interventions

Valproate sodium

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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VALID : VAlproate Versus LIthium in Bipolar Disorders

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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