Comparative Evaluation of QUEtiapine-Lamotrigine combination versus quetiapine monotherapy (and folic acid versus placebo) in people with bipolar depressio

Not Applicable

Completed

• Conditions: Bipolar depression; Mental and Behavioural Disorders; Bipolar affective disorder

• Registration Number: ISRCTN17054996
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-29
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 202

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified