NCT00126009

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2005

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
Last Updated

April 10, 2008

Status Verified

April 1, 2008

First QC Date

July 18, 2005

Last Update Submit

April 8, 2008

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Interventions

AmisulprideDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sanofi-Aventis

Prague, Czechia

Location

Sanofi-Aventis

Paris, France

Location

Sanofi-Aventis

Warsaw, Poland

Location

Sanofi-Aventis

Bratislava, Slovakia

Location

Sanofi-Aventis

Barcelona, Spain

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Amisulpride

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Gilles Perdriset, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 18, 2005

First Posted

August 2, 2005

Study Start

May 1, 2004

Last Updated

April 10, 2008

Record last verified: 2008-04

Locations

ES(1)CZ(1)FR(1)PL(1)SL(1)