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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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CEQUEL
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Comparative Evaluation of QUEtiapine-Lamotrigine combination versus quetiapine monotherapy (and folic acid versus placebo) in people with bipolar depression
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Topic
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Mental Health (co-adopted by PCRN)
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Portfolio Eligibility
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Funded by UKCRC partner
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ISRCTN
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17054996
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EudraCT
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2007-004513-33
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MREC N° |
08/H0605/39
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UKCRN ID |
4400
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WHO ID
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Research Summary
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Background: Much of the burden of bipolar disorder is caused by depressive symptoms. Bipolar depression is often treated in the same way as major depressive disorder but there is little evidence that this is effective and concern that some treatments will increase the risk of switch to a manic state. CEQUEL is designed to address the urgent need to identify effective treatments that:
- provide safe, tolerable and rapid reduction of depressive symptoms, - avoid induction of manic symptoms in the short- term,
- maintain continued remission from depressive symptoms and freedom from manic symptoms in the longer-term.
Interventions: The NICE guidelines on treatment of bipolar disorder include quetiapine, an atypical antipsychotic, as a first-line treatment for depression. Evidence from RCTs suggests that quetiapine provides rapid relief of acute depression but has a high incidence of sedation and study withdrawal indicating the need for alternative treatments. There is also evidence that lamotrigine, an anticonvulsant, is tolerable and may be moderately effective for bipolar depression but the need for slow titration can lead to delayed therapeutic response. CEQUEL will explore the possibility that the combination quetiapine and lamotrigine will be more effective than quetiapine alone both for acute treatment of depressive symptoms and for longer-term maintenance of remission and prevention of depressive or manic relapse.
There is also evidence that folic acid, vitamin B9, can increase response to antidepressant treatments. CEQUEL will compare folic with placebo as adjunctive therapy and explore these subgroup effects.
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Study Type |
Interventional
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Design Type |
Treatment
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Disease(s) |
Bipolar affective disorder
Depression
All Diseases
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Phase |
IV
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Current Status
| Open |
| Closure Date | 31/03/2011 |
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Sample Size
| 584 |
| Accrual to Date |
 24% |
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Geographical Scope
| UK Multi-Centre |
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Lead Country
| England |
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Open to new sites
| Yes, within and outside lead country |
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Main Inclusion Criteria
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For entry to the randomised phase:
1. primary diagnosis of bipolar disorder type I or II
2. consent to participate in the trial
3. aged 16 or over
4. current depressive episode requiring new pharmacological
treatment
5. QIDS-SR16 score ≥ 11
6. uncertainty whether quetiapine plus lamotrigine would be more
effetive than quetiapine monotherapy
7. able to tolerate quetiapine at a dose of at least 150mg/day
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Main Exclusion Criteria
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1. contraindications to lamotrigine or quetiapine
2. current manic or mixed episode
3. primary diagnosis of schizophrenia
4. recently begun or about to begin specific psychosocial intervention
4. currently pregnant or breast feeding or planning pregnancy
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Chief Investigator(s)
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| Prof John Geddes |
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Further details, please contact
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Mrs Alexandra Gardiner
University of Oxford
Department of Psychiatry
Warneford Hospital
Warneford Lane
Headington
Oxford
Oxfordshire
OX3 7JX
UNITED KINGDOM
Tel: 01865 223731
Fax: 01865 223900
alex.gardiner@psych.ox.ac.uk
| Dr Jennifer Rendell
Warneford Hospital
University Department of Psychiatry
Warneford Lane
Headington
Oxford
Oxfordshire
OX3 7JX
UNITED KINGDOM
Tel: 01865 226465
Fax: 01865 223900
jennifer.rendell@psych.ox.ac.uk
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Funder(s) |
Medical Research Council
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Sponsor(s) |
University of Oxford
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