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Atypical Antipsychotics for Continuation and Maintenance Treatment After an Acute Manic Episode

NCT01977300 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2015-11-20

No results posted yet for this study

Summary

Hypothesis: Continuation of an atypical antipsychotic medication in combination with a Mood Stabilizer, following remission from an acute manic episode, lowers the rates of relapse and recurrence of mood episodes compared to discontinuing the antipsychotics within days of resolution of manic symptoms.

Conditions

Interventions

DRUG

Valproate

serum level of 50 to 125 ug/L

DRUG

Lithium

serum levels of 0.6 to 1.2 mmol/L

DRUG

Risperidone

1 to 6 mg/day

DRUG

Olanzapine

5 to 25 mg/day

OTHER

Placebo

manufactured to mimic risperidone and olanzapine

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Janssen-Ortho Inc., Canada

    collaborator INDUSTRY

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Lakshmi N Yatham, Dr. · University of British Columbia

  • Serge Beaulieu, Dr. · McGill University, Montreal

  • Andree Daigneault, Dr. · Clinique des Maladies Affectives, Montreal

  • Verinder Sharma, Dr. · Regional Mental Health Care London, Ont.

  • Hubert Wong, Dr. · University of British Columbia

  • Ayal Schaffer, Dr. · Sunnybrook Health Sciences Centre, Toronto, Ont.

  • Sagar Parikh, Dr. · Centre for Addiction and Mental Health, Toronto, Ont.

  • Philippe Baruch, Dr. · Clinique des troubles de l'humeur, Quebec

  • Peter Silverstone, Dr. · University of Alberta

  • Roumen Milev, Dr. · Providence Continuing Care, Kingston, Ont.

  • Ram Veluri, Dr. · Northern Health Research Inc., Sudbury, Ont.

  • Pablo Cervantes, Dr. · Montreal General, Quebec

  • Claire O'Donovan, Dr. · Mental Health Services, Halifax, NS

  • Flavio Kapczinski, Dr. · Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil

  • Benny Lafer, Dr. · Instituto de Psiquiatria do Hospital das Clínicas, Sao Paulo, Brazil

  • Angelo B Miralha da Cunha, Dr. · Santa Maria, Brazil

  • Joao Quevedo, Dr. · Casa de Saude do Rio Maina Ltda, Criciuma, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Canada

Study Locations

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Entities

Drugs
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 NCT01977300 on ClinicalTrials.gov