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Is it possible to modify the course of manic relapse? A pilot study of the effectiveness of quetiapine in preventing the development of manic episodes in Bipolar Disorder. - Is it possible to modify the course of manic relapse?

Is it possible to modify the course of manic relapse? A pilot study of the effectiveness of quetiapine in preventing the development of manic episodes in Bipolar Disorder. - Is it possible to modify the course of manic relapse?

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005072-32-GB
Enrollment
50
Registered
2005-10-27
Start date
2005-12-19
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Interventions

Trade Name: Seroquel 100mg Product Name: Quetiapine Pharmaceutical Form: Film-coated tablet Trade Name: Seroquel 150mg Product Name: Qu

Sponsors

Kings College London (IOP) / South London and Maudsley NHS Trust (Co-sponsorship)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: For inclusion in the study subjects must fulfil all of the following criteria: 1.Provision of written informed consent. 2.A Youngs mania rating scale (YMRS) score of 13-20. (score of 20 regarded as mania) 3.A current diagnosis of Bipolar I disorder, as defined by DSM IV with at least 1 episode of manic relapse in the previous 6 months. 4.A history of compliance with previous medication regimes. 5.Engagement with the mental health services. 6.Males or females aged 18-65. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study: 1.Patients having taken antidepressant medication within 30 days prior to study enrolment. 2.Patients currently enrolled in clinical trials with mood stabilizer or antipsychotic medications (including the BALANCE trial). 3.Drug or alcohol dependence as defined by DSM IV. 4.Known non-responders to an adequate treatment with quetiapine. 5.Thyroid function abnormality 6.Pregnant or lactating females.

Design outcomes

Primary

MeasureTime frame
Main Objective: Primary objective The primary objective of this study is to assess the clinical effectiveness and tolerability of quetiapine in combination with mood stabilising medication in treating the manic prodrome in Bipolar I disorder. ; Secondary Objective: Secondary objectives of the study are 1.To confirm that treatment with quetiapine does not worsen depressive symptoms present in prodromal manic relapse in Bipolar I disorder. 2.To assess the impact of quetiapine on patients quality of life (including attitudes to medication) and health economics data. ; Primary end point(s): Change in YMRS (Youngs Mania Rating scale) score over time change in CGI (Clinical Global Impression) score over time—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026