Comparative Evaluation of QUEtiapine-Lamotrigine combination versus quetiapine monotherapy (and folic acid versus placebo) in patients with bipolar depression - CEQUE

Phase 1

Active, not recruiting

• Conditions: Bipolar depression; MedDRA version: 13.1 Level: LLT Classification code 10004936 Term: Bipolar depression System Organ Class: 10037175 - Psychiatric disorders

• Registration Number: EUCTR2007-004513-33-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-20
• Study Completion: 2013-04-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 202

Inclusion Criteria

For randomisation:
1. primary diagnosis of DSM-IV bipolar disorder type I or II
2. consent to randomisation
3. aged 16 or over
4. current depressive episode requiring new pharmacological treatment
5. Quick Inventory of Depressive Symptomatology, self-report version (QIDS-SR16) score at least 11
6. uncertainty whether quetiapine plus lamotrigine would be more effective than quetiapine monotherapy
7. ability to tolerate quetiapine at a dose of at least 150mg/day
8. acceptable adherence to quetiapine (>90%) and self-report SMS satisfactory
9. Willing to accepr random allocation of treatments
10. in the opinion of the investigator, not currently experiencing manic or mixed episode.

Are the trial subjects under 18? yes
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

For randomisation:
1. definite indications or contraindications to lamotrigine, quetiapine or folic acid* (including pregnancy and 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 experiencing manic or mixed episode
5. primary diagnosis of schizophrenia

Plus, for women of child-bearing potential
6.not using adequate contraception or currently breast feeding.

* if contraindications are to folic acid/placebo only the person can enter the trial and be randomly allocated lamotrigine/placebo but not folic acid/placebo.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified