SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00126009
First received: July 18, 2005
Last updated: April 8, 2008
Last verified: April 2008
  Purpose

The primary objective is:

  • To compare the efficacy of the association valproate-amisulpride (400 to 800 mg/day) to the association valproate-haloperidol (5 to 15 mg/day) in bipolar I patients suffering from a manic episode according to DSM IV TR (American Psychiatric Association [APA] 2000) and treated for a 3-month period.

The secondary objectives are:

  • To evaluate the clinical and biological safety of the association valproate-amisulpride to the association valproate-haloperidol;
  • To assess the patient status 3 weeks and 3 months after inclusion; and
  • To assess patient satisfaction at 3 months.

Condition Intervention Phase
Bipolar Disorder
Drug: Amisulpride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 3-Month, Open, Randomised Trial Comparing the Efficacy and Safety of the Association Valproate-Amisulpride to the Association Valproate-Haloperidol in Bipolar I Patients Suffering From a Manic Episode

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Combination of the percentage of responders defined by a decrease of at least 50% of the Y-MRS (Young Mania Rating Scale) between D0 and D END and the completion of the 3-month treatment period.

Secondary Outcome Measures:
  • Other efficacy criteria (such as the changes in Y-MRS scores between D0 and D 21, between D0 and D END.The percentage of remission defined as the Y-MRS < or = 12 at D END...). Safety data (clinical, ECG and laboratory data)

Estimated Enrollment: 120
Study Start Date: May 2004
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Pre-Inclusion Criteria on D-3:

  • In-patients
  • From 18 to 65 years old
  • Able to comply with the protocol
  • Having given their written informed consent (with a legal representative or a person of trust)
  • Current diagnosis of bipolar I disorder according to DSM IV TR (APA 2000)
  • Having had at least one manic episode in the past
  • Currently suffering from a manic episode according to DSM IV TR (APA 2000)
  • A minimum total score of 20 on the Young Mania Rating Scale (Y-MRS) at D-3

Inclusion Criteria on D0:

  • Having completed at least one day of the one to three-day washout period
  • A minimum total score of 20 on the Young Mania Rating Scale at D0
  • A score of > or = 3 for 2 of the following Y-MRS items: elevated mood; increased motor activity energy; sleep; content (grandiosity).
  • A score of > or = 5 on the Clinical Global Impression Severity Scale for the severity of mania items at D0
  • Using an effective contraception method (women of childbearing age only)

Exclusion Criteria:

Exclusion Criteria on D-3:

  • Having participated in a clinical trial within the three previous months
  • Pregnant or breast-feeding. Female patients should therefore be using reliable contraceptive methods (oral or parenteral contraception, intra-uterine device or surgical sterilisation)
  • Uncontrolled gastro-intestinal, renal, hepatic, endocrine, cardiovascular, pulmonary, immunological or hematological disease
  • Central nervous system (CNS) neoplasm; demyelinating disease; degenerative neurological disorder; active CNS infection; or any progressive disorder that may confound interpretation of the study results
  • Prolactin-dependant tumor
  • Past or current pancreatitis
  • Acute hepatitis, chronic hepatitis, or family history of severe hepatitis, especially drug related, hepatic porphyry
  • Current or recent (within 3 months) DSM IV diagnosis of substance dependence (with the exception of nicotine or caffeine dependence); or substance abuse with stimulants including, but not limited to, cocaine, crack, amphetamines, pseudoephedrine, cold medications with phenylephrine, or other stimulants. Alcohol and marijuana abuse prior to study entry would be acceptable if related to the current manic episode, based on the investigator's judgement
  • Parkinson's disease
  • Phaeochromocytoma
  • History of epilepsy
  • History of allergy or hypersensitivity to haloperidol or benzamides or valproate
  • Treated with fluoxetin within the past 4 weeks
  • Treated with injectable long-acting neuroleptics if, for the patient, the interval between 2 injection periods has not elapsed before pre-inclusion (D-3)
  • Treated with a mood stabiliser (other than valproate) at effective dose for less than 7 days preceding D-3 and for whom a modification is not justified
  • Bradycardia < 55 beats per minute (bpm)
  • Known hypokaliaemia
  • Congenital prolongation of the QT interval
  • Treated with any of the following medications: Class Ia antiarrhythmic agents such as quinidine, disopyramide/Class III antiarrhythmic agents such as amiodarone, sotalol; Drugs like: beperidil, cisapride, sultopride, thioridazine, intravenous (IV) erythromycin, IV vincamine, halofantrine, pentamidine, or sparfloxacin.

Exclusion Criteria on D0:

  • Potentially significant alterations of laboratory tests on D0:

    • ASAT or ALAT > 2 upper limit of normal (ULN). If ASAT or ALAT values range between 1.5 ULN and 2 ULN, the patient can be randomized and a new test will be performed 7 days after randomization;
    • Alkaline phosphatase levels or bilirubin levels not within normal reference range.
  • QTc prolongation on D0; QTc Bazett > 450ms in male patients and QTc > 470ms in female patients on electrocardiogram (ECG).
  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: NCT00126009

Locations
Czech Republic
Sanofi-Aventis
Prague, Czech Republic
France
Sanofi-Aventis
Paris, France
Poland
Sanofi-Aventis
Warsaw, Poland
Slovakia
Sanofi-Aventis
Bratislava, Slovakia
Spain
Sanofi-Aventis
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Gilles Perdriset, MD Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00126009     History of Changes
Other Study ID Numbers: C_8428
Study First Received: July 18, 2005
Last Updated: April 8, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Haloperidol
Sultopride
Anti-Dyskinesia Agents
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014