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

NCT00126009 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2008-04-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Amisulpride

Sponsors & Collaborators

Principal Investigators

  • Gilles Perdriset, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31

Countries

  • Czechia
  • France
  • Poland
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00126009 on ClinicalTrials.gov