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| Comparative Evaluation of QUEtiapine-Lamotrigine combination versus quetiapine monotherapy (and folic acid versus placebo) in patients with bipolar depression |
| Source of record | UK Trials |
| ISRCTN | ISRCTN17054996 |
| Date ISRCTN assigned | 29/02/2008 |
| Local reference number(s) | OCTUMI-02:CEQUEL; MRC ref: 81651 |
| Public title | Comparative Evaluation of QUEtiapine-Lamotrigine combination versus quetiapine monotherapy (and folic acid versus placebo) in patients with bipolar depression |
| Scientific title | |
| Acronym | CEQUEL |
| Disease/condition/study domain | Bipolar depression |
| Study hypothesis | The combination of quetiapine and lamotrigine will be more effective than quetiapine alone as treatment for acute bipolar depression |
| Design/methodology | Multi-centre, double-blind, randomised, placebo-controlled, parallel group, 2 x 2 factorial clinical trial. |
| Research ethics review | To be submitted as of 10 January 2008. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | For the active run-in phase: 1. Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) bipolar disorder type I or II (assessed using the Mini-International Neuropsychiatric Interview [MINI]) 2. Consent to participate in the trial 3. Aged 16 or over 4. Current depressive episode requiring new pharmacological treatment (either as add-on therapy or as a change of treatment) 5. Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16) Score >= 14 For the randomised phase: 1. Able to tolerate quetiapine at a dose of at least 150 mg/day 2. Uncertainty whether quetiapine plus lamotrigine would be more effective than quetiapine monotherapy 3. Acceptable adherence to quetiapine (>90%) and to self-report SMS text-messages satisfactory 4. QIDS-SR16 score of >=11 on day of randomisation 5. Willing to accept random allocation of treatments 6. In the opinion of the investigator, not currently experiencing manic or mixed episode |
| Participants - exclusion criteria | 1. Definite indications or contraindications to lamotrigine, quetiapine or folic acid (Including pregnancy or planned pregnancy) 2. New course of structured psychotherapy started in the past four weeks 3. First appointment for structured psychotherapy booked within the next 14 weeks 4. Currently meeting criteria for (hypo)mania (based on MINI) 5. Eight or more mood episodes in the past year Plus, for women of child-bearing potential: 6. Not using adequate contraception |
| Patient information material | |
| Anticipated start date | 01/04/2008 |
| Anticipated end date | 31/03/2012 |
| Status of trial | Ongoing |
| Target number of participants | 584 |
| Interventions | 1. Open-label quetiapine (oral) plus 2. Lamotrigine (oral) or placebo plus 3. Folic acid (oral) or placebo The recommended dose of quetiapine is 300 mg/day but this can be reduced if the higher dose is not tolerated. Minimum dose 150 mg/day. Quetiapine will be taken for about 54 weeks (1-2 week run-in phase and 12 month randomised phase). The recommended dose of lamotrigine is 200 mg/day (reduced to 100 mg/day for participants taking concurrent valproic acid preparations). Lamotrigine will be taken for the 12 months randomised phase. Dose of folic acid: 500 µg/day. Folic acid will be taken for the 12 months randomised phase. |
| Primary outcome measure(s) | Remission of depressive symptoms at 12 weeks post-randomisation. |
| Secondary outcome measure(s) | 1. The proportion of participants who both achieve remission by 12 weeks following randomisation (defined as a score of <= 5 on QIDS-SR16) and remain free from symptomatic relapse by 52 weeks. Depressive relapse is defined as a QIDS-SR16 score >= 10 on two consecutive weekly ratings and manic relapse as an Altman Self-Rating Mania Scale (ASRM) score of >=10 on a single weekly rating. 2. New intervention (admission or drug treatment) for manic episode by 52 weeks. 3. New intervention (admission or drug treatment) for depressive episode by 52 weeks. 4. Proportion of time over 12 months when participants were free from manic symptoms (ASRM <= 5). 5. Proportion of time over 12 months when participants were free from depressive symptoms (QIDS-SR16 <= 5). 6. Death (all cause and cause-specific including suicide). 7. Deliberate self-harm. 8. Quality of life, rated using the EuroQol EQ-5D (timepoint of measurement not yet defined as of 21 January 2008). 9. Unexpected adverse events. 10 Withdrawal from quetiapine or lamotrigine due to adverse effects. 11. Use of health and social care service resources. 12. Social costs/benefits. |
| Trial website | http://www.cequel.org |
| Sources of funding | Medical Research Council (ref: 81651) (UK) |
| Sponsor name | University of Oxford (UK) |
| Sponsor details | Clinical Trials and Research Governance Manor House John Radcliffe Hospital Headington Oxford United Kingdom OX3 9DU |
| Sponsor website | Http://www.ox.ac.uk |
| Contact name | Prof John Geddes |
| Contact details | Department of Psychiatry Warneford Hospital Oxford United Kingdom OX3 7JX |
| Contact telephone | +44 (0)1865 226480 |
| Contact fax | +44 (0)1865 223900 |
| Contact email | john.geddes@psych.ox.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN17054996 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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