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

NCT ID: NCT01977300

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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This is a randomised, double-blind, placebo controlled trial over 52 weeks. Patients will be on one of four combinations of medications at the time of entry into the study: a) lithium and risperidone, b) lithium and olanzapine, c) valproate and risperidone, or d) valproate and olanzapine. After obtaining informed consent, patients will be randomised to one of three groups 1)"0" week group: patients will receive lithium or valproate plus placebo for 52 weeks (risperidone or olanzapine tapering will begin on the day of randomisation with discontinuation of the drug within 2 weeks), 2) continuation of the same atypical antipsychotic, risperidone or olanzapine, plus lithium or valproate for 24 weeks (tapering of the antipsychotic begins at the end of 24 weeks and completed within 2 weeks) followed by the same mood stabilizer plus placebo for another 28 weeks, and 3) continuation of the atypical antipsychotic, risperidone or olanzapine, plus lithium or valproate for 52 weeks. The duration of the double-blind phase of the study will be 52 weeks and all patients will continue on the mood stabilizer, lithium or valproate, they had been on during the acute mania for the full duration of the study. The serum level of the mood stabilizer will be maintained within the therapeutic range (0.6 to 1.2 mmol/L for lithium and 50 to 125 ug/L for valproate) throughout the 52 weeks as determined by blood tests. The dose and the type of atypical antipsychotic (ie risperidone or olanzapine) each patient will receive during the double-blind period will be the same that the patient had been on at the time of entry into the double-blind phase. All patients, irrespective of which treatment arm they are in, will receive active psychoeducation and counselling regarding sleep hygiene, healthy daily routines and rhythms, alcohol and substance abuse, anxiety management, conflict resolution and problem solving as clinically indicated in routine clinical practice. Patients who withdraw from or meet a primary end point of the study will be treated actively as done in regular clinical practice.

Patients will not be allowed to receive any other psychotropic medication with the exception of benzodiazepines for sedation and anti-parkinsonian medication for extrapyramidal side effects. The doses of these will be recorded.

Conditions

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Bipolar I Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mood stabilizer & Placebo

Patients will receive lithium or valproate plus placebo for 52 weeks (risperidone or olanzapine tapering will begin on the day of randomization with discontinuation of the drug within 2 weeks).

Group Type PLACEBO_COMPARATOR

Valproate

Intervention Type DRUG

serum level of 50 to 125 ug/L

Lithium

Intervention Type DRUG

serum levels of 0.6 to 1.2 mmol/L

Placebo

Intervention Type OTHER

manufactured to mimic risperidone and olanzapine

'24 week " arm

Continuation of the lithium or valproate plus risperidone or olanzapine for 24 weeks followed by mood stabilizer plus placebo for another 28 weeks. Dosages: 1 to 6 mg of risperidone, 5 to 20 mg olanzapine.

Group Type EXPERIMENTAL

Valproate

Intervention Type DRUG

serum level of 50 to 125 ug/L

Lithium

Intervention Type DRUG

serum levels of 0.6 to 1.2 mmol/L

Risperidone

Intervention Type DRUG

1 to 6 mg/day

Olanzapine

Intervention Type DRUG

5 to 25 mg/day

Placebo

Intervention Type OTHER

manufactured to mimic risperidone and olanzapine

"52 week" arm

Continuation of the atypical antipsychotic, risperidone or olanzapine, plus lithium or valproate for 52 weeks.

Group Type ACTIVE_COMPARATOR

Valproate

Intervention Type DRUG

serum level of 50 to 125 ug/L

Lithium

Intervention Type DRUG

serum levels of 0.6 to 1.2 mmol/L

Risperidone

Intervention Type DRUG

1 to 6 mg/day

Olanzapine

Intervention Type DRUG

5 to 25 mg/day

Interventions

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Valproate

serum level of 50 to 125 ug/L

Intervention Type DRUG

Lithium

serum levels of 0.6 to 1.2 mmol/L

Intervention Type DRUG

Risperidone

1 to 6 mg/day

Intervention Type DRUG

Olanzapine

5 to 25 mg/day

Intervention Type DRUG

Placebo

manufactured to mimic risperidone and olanzapine

Intervention Type OTHER

Other Intervention Names

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Valproic Acid Lithium Carbonate Risperdal Zyprexa Sugar Pill

Eligibility Criteria

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Inclusion Criteria

* Patients who were recently (within the last 12 weeks) commenced on treatment for a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) manic or mixed episode with a combination of lithium and risperidone, lithium and olanzapine, valproate and risperidone, or valproate and olanzapine;
* Patients on 1 to 6 mg of risperidone or 5 to 25 mg of olanzapine
* Patients who are in remission from mania for at least 2 weeks but no more than 6 weeks and have maintained remission for 2 consecutive weeks;
* Patients must not be taking any other psychotropic medication (with the exception of benzodiazepines) or treatments including bromocriptine, omega 3 fatty acids, Axid or EMPower;
* Patients aged 17 and above.

* In order for the findings to be generalizable to clinically representative patients with bipolar disorder, any patients with a history of co-morbid substance abuse or medical illnesses will not be excluded.
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Janssen-Ortho Inc., Canada

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lakshmi N Yatham, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Serge Beaulieu, Dr.

Role: STUDY_DIRECTOR

McGill University, Montreal

Andree Daigneault, Dr.

Role: STUDY_DIRECTOR

Clinique des Maladies Affectives, Montreal

Verinder Sharma, Dr.

Role: STUDY_DIRECTOR

Regional Mental Health Care London, Ont.

Hubert Wong, Dr.

Role: STUDY_DIRECTOR

University of British Columbia

Ayal Schaffer, Dr.

Role: STUDY_DIRECTOR

Sunnybrook Health Sciences Centre, Toronto, Ont.

Sagar Parikh, Dr.

Role: STUDY_DIRECTOR

Centre for Addiction and Mental Health, Toronto, Ont.

Philippe Baruch, Dr.

Role: STUDY_DIRECTOR

Clinique des troubles de l'humeur, Quebec

Peter Silverstone, Dr.

Role: STUDY_DIRECTOR

University of Alberta

Roumen Milev, Dr.

Role: STUDY_DIRECTOR

Providence Continuing Care, Kingston, Ont.

Ram Veluri, Dr.

Role: STUDY_DIRECTOR

Northern Health Research Inc., Sudbury, Ont.

Pablo Cervantes, Dr.

Role: STUDY_DIRECTOR

Montreal General, Quebec

Claire O'Donovan, Dr.

Role: STUDY_DIRECTOR

Mental Health Services, Halifax, NS

Flavio Kapczinski, Dr.

Role: STUDY_DIRECTOR

Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil

Benny Lafer, Dr.

Role: STUDY_DIRECTOR

Instituto de Psiquiatria do Hospital das Clínicas, Sao Paulo, Brazil

Angelo B Miralha da Cunha, Dr.

Role: STUDY_DIRECTOR

Santa Maria, Brazil

Joao Quevedo, Dr.

Role: STUDY_DIRECTOR

Casa de Saude do Rio Maina Ltda, Criciuma, Brazil

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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Yatham LN, Beaulieu S, Schaffer A, Kauer-Sant'Anna M, Kapczinski F, Lafer B, Sharma V, Parikh SV, Daigneault A, Qian H, Bond DJ, Silverstone PH, Walji N, Milev R, Baruch P, da Cunha A, Quevedo J, Dias R, Kunz M, Young LT, Lam RW, Wong H. Optimal duration of risperidone or olanzapine adjunctive therapy to mood stabilizer following remission of a manic episode: A CANMAT randomized double-blind trial. Mol Psychiatry. 2016 Aug;21(8):1050-6. doi: 10.1038/mp.2015.158. Epub 2015 Oct 13.

Reference Type BACKGROUND
PMID: 26460229 (View on PubMed)

Other Identifiers

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V02-0130

Identifier Type: OTHER

Identifier Source: secondary_id

H02-70188

Identifier Type: -

Identifier Source: org_study_id