Condition category
Mental and Behavioural Disorders
Date applied
01/09/2005
Date assigned
01/09/2005
Last edited
24/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lakshmi N. Yatham

ORCID ID

Contact details

Mood Disorders Centre
University of British Columbia
2255 Westbrook Mall
Rm 2C7
Vancouver
British Columbia
V6T 2A1
Canada
+1 604 822 7325
yatham@interchange.ubc.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-53576

Study information

Scientific title

Atypical antipsychotics for continuation and maintenance treatment after an acute manic episode: a randomised controlled trial

Acronym

Study hypothesis

We hypothesise that continuing risperidone or olanzapine for 6 or 12 months (along with a mood stabiliser) will lead to significantly lower rates of relapse or recurrence of mood episodes compared with mood stabiliser monotherapy for 12 months, in bipolar patients currently in remission but recently treated for an acute manic episode with a mood stabiliser and risperidone or olanzapine combination.

Ethics approval

University of Western Ontario, Office of Research Ethics gave approval on the 31st May 2005

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Bipolar disorder

Intervention

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 stabiliser plus placebo for another 28 weeks
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 stabiliser, lithium or valproate, they had been on during the acute mania for the full duration of the study

Intervention type

Drug

Phase

Not Applicable

Drug names

Risperidone, olanzapine, lithium, valproate

Primary outcome measures

Time to any mood episode.

Secondary outcome measures

1. Time to premature discontinuation from the study for any clinical reason (dose change in medication, new intervention, side effects, etc.)
2. Time to manic episode
3. Time to depressive episode
4. Proportion of patients gaining more than 7% of body weight (this amount of weight gain is significant for cardiovascular morbidity)
5. Proportion of patients developing extrapyramidal symptoms, tardive dyskinesia, prolactin related side effects
6. Changes in YMRS, HAM-D 21, CGI-S, ESRS scores and weight during the study period

Overall trial start date

01/04/2002

Overall trial end date

30/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who were recently (within the last 12 weeks) commenced on treatment for a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) manic or mixed episode with a combination of lithium and risperidone, lithium and olanzapine, valproate and risperidone, or valproate and olanzapine
2. Patients who are in remission from mania for at least 2 weeks but no more than 6 weeks. Remission is defined as either:
2.1. A Clinical Global Impression - Severity (CGI-S) scale score of 2 (borderline mentally ill) or less (normal, not ill) for 2 consecutive weeks
2.2. A YMRS score of 8 or less (normal range) and a Hamilton Rating Scale for Depression (HAM-D) 21-item score of 8 or less (normal range) for 2 consecutive weeks
3. Must not be taking any other psychotropic medication with the exception of benzodiazepines (maximum of lorazepam 4 mg per day or its equivalent)
4. Patients aged 18 and above (efficacy of risperidone and olanzapine is not tested in those below 18 years of age), either sex
5. Patients on 1 to 6 mg risperidone or 5 to 25 mg olanzapine (these are the dose ranges commonly used in clinical practice, and are shown to be effective doses in acute mania trials)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

540

Participant exclusion criteria

As we want the findings to be generalisable to clinically representative patients with bipolar disorder, we will not exclude any patients with a history of co-morbid substance abuse or medical illnesses. Any subjects who do not meet the above inclusion criteria will be excluded from the study.

Recruitment start date

01/04/2002

Recruitment end date

30/03/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Mood Disorders Centre
Vancouver, British Columbia
V6T 2A1
Canada

Sponsor information

Organisation

University of British Columbia (Canada)

Sponsor details

2075 Wesbrook Mall
Vancouver
British Columbia
V6T 1Z1
Canada

Sponsor type

University/education

Website

http://www.ubc.ca/

Funders

Funder type

Other

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-53576)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Janssen-Ortho Canada, Inc. (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Eli Lilly Canada, Inc. (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes