VALID : VAlproate Versus LIthium in Bipolar Disorders

NCT00264173 | Completed Phase 4

• 1 other identifier: R_8740
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Change from baseline to D END in the Young Mania Rating Scale total score

Secondary Outcomes (8)

• Change from baseline to each assessment in the YMRS score

• Percentage of responders defined by a decrease of at least 50% in the YMRS score between D0 and D END

• Percentage of responders at week 3 defined by a decrease of at least 50 % in the YMRS score between D0 and D21

• Change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) (20) between D0 and D21

• Change in the CGI-BP between D0 and D END

Interventions

Valproate sodium DRUG

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnancy or lactation. Women of child bearing age should therefore be using a reliable contraceptive method
• Patients that require more than 300 mg of aspirin per day
• Patients with a medical condition which requires the continuous use of a treatment which could interfere with the safety or efficacy evaluation of valproate (anticonvulsant or anticoagulant therapy, zidovudine) or lithium (angiotensin converting enzyme inhibitors, tetracycline, reserpine, calcium channel blockers, triptans)
• Patients who received injectable long-acting neuroleptics less than 7 days prior to Screening
• Patients necessitating an Electro Convulsive Therapy

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Robert MANFREDI, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 9, 2005
• First Posted: December 12, 2005
• Study Start: February 1, 2004
• Study Completion: September 1, 2006
• Last Updated: November 16, 2007

Record last verified: 2007-11