Comparative Evaluation of QUEtiapine-Lamotrigine combination versus quetiapine monotherapy (and folic acid versus placebo) in people with bipolar depression
| ISRCTN | ISRCTN17054996 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17054996 |
| Protocol serial number | MRC ref: 81651; OCTUMI-02:CEQUEL |
| Sponsor | University of Oxford (UK) |
| Funder | Medical Research Council (MRC) (UK) (ref: 81651) |
- Submission date
- 10/01/2008
- Registration date
- 29/02/2008
- Last edited
- 26/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof John Geddes
Scientific
Scientific
Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
| Phone | +44 (0)1865 226480 |
|---|---|
| john.geddes@psych.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre double-blind randomised placebo-controlled parallel-group, 2 x 2 factorial clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparative Evaluation of QUEtiapine-Lamotrigine combination versus quetiapine monotherapy (and folic acid versus placebo) in people with bipolar depression |
| Study acronym | CEQUEL |
| Study objectives | The combination of quetiapine and lamotrigine will be more effective than quetiapine alone as treatment for acute bipolar depression. Please note that this trial has been updated since the original submission. All changes can be found in the relevant field under the update date of 28/04/2008. The previous title of this trial was 'Comparative Evaluation of QUEtiapine-Lamotrigine combination versus quetiapine monotherapy (and folic acid versus placebo) in patients with bipolar depression', and the previous anticipated start date of this trial was 01/04/2008. More details can be found at: http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0700477&CaseId=9701 On 20/12/2013 the anticipated end date was changed from 31/03/2012 to 05/05/2013 and the target number of participants field was changed from 584 to 202. |
| Ethics approval(s) | Oxfordshire Research Ethics Committee B, 09/04/2008, ref: 08/H0605/39 |
| Health condition(s) or problem(s) studied | Bipolar depression |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Quetiapine, lamotrigine |
| Primary outcome measure(s) |
Remission of depressive symptoms at 12 weeks post-randomisation. |
| Key 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. |
| Completion date | 05/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 202 |
| Key inclusion criteria | For the active run-in phase: 1. Primary diagnosis of bipolar disorder type I or II (based on Diagnostic and Statistical Manual of Mental Disorders, 4th edition [DSM-IV] criteria for a hypomanic or manic episode) 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 Please note that, as of 15/09/2008, inclusion criterion "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])" has been replaced with "1. Primary diagnosis of bipolar disorder type I or II (based on Diagnostic and Statistical Manual of Mental Disorders, 4th edition [DSM-IV] criteria for a hypomanic or manic episode)" 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 |
| Key exclusion criteria | Current exclusion criteria as of 15/09/2008: 1. Definite indications or contraindications to lamotrigine, quetiapine or folic acid (Including pregnancy or planned pregnancy) 2. New course of specific psychosocial intervention started in the past four weeks 3. First appointment for specific psychosocial intervention booked within the next 14 weeks 4. Primary diagnosis of schizophrenia Plus, for women of child-bearing potential: 5. Currently breast feeding or not using adequate contraception Current exclusion criteria as of 28/04/2008: 1. Definite indications or contraindications to lamotrigine, quetiapine or folic acid (Including pregnancy or planned pregnancy) 2. New course of specific psychosocial intervention started in the past four weeks 3. First appointment for specific psychosocial intervention booked within the next 14 weeks 4. Currently meeting criteria for (hypo)mania (based on MINI) 5. Currently meeting criteria for schizophrenia 6. Eight or more mood episodes in the past year Plus, for women of child-bearing potential: 7. Not using adequate contraception Initial 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 |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 05/05/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Psychiatry
Oxford
OX3 7JX
United Kingdom
OX3 7JX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results: | 01/01/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/10/2016: Publication reference added
