BALANCE 2: Bipolar disorder:Antidepressant/Lamotrigine/ANtipsychotic Comparative Evaluation - BALANCE 2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001317-15-GB

Enrollment

630

Registered

2006-04-11

Start date

2006-05-09

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar depression.

Interventions

Trade Name: Quetiapine Pharmaceutical Form: Film-coated tablet Product Name: Selective Serotonin Reuptake Inhibitors Product Code: SSRI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of DSM-IV bipolar I, II or spectrum disorder 2, Current depressive episode requiring new pharmacological treatment (change of SSRI or addition of a new SSRI would constitute new treatment but an increase in the dose of a current SSRI would not). 3. Uncertainty whether SSRI, quetiapine or lamotrigine would be safer and more effective in the short and medium term 4. Consent to randomization 5. Aged 16 or over 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

Exclusion criteria: 1. Contraindication to SSRIs 2. Contraindication to lamotrigine 3. Contraindication to quetiapine 4. Ongoing treatment or treatment for this episode with lamotrigine or quetiapine 5. Eight or more mood episodes in the past year 6. For patients with bipolar I disorder, unwillingness to take adjunctive therapy 7. Evidence of poor adherence to prescribed medicines

Design outcomes

Primary

Measure	Time frame
Primary end point(s): 1. Total score on the Quick Inventory of Depressive Symptomatology, Clinician version QIDS-C16 at 12 weeks. 2. Time to (hypo)manic episode. ;Secondary Objective: Secondary objectives include the comparison of the three treatments in terms of continuing remission of depresssive symptoms, deliberate self-harm, unexpected adverse effects and mortality.; Main Objective: BALANCE 2 will compare the efficacy of SSRI, quetiapine and lamotrigine in the treatment of acute episodes of bipolar depression. SSRIs and quetiapine will each be compared to lamotrigine in terms of reduction of depressive symptoms at 12 weeks. Quetiapine and lamotrigine will each be compared to SSRIs in terms of risk or switch to mania. The costs, effects and cost-effectiveness of the three treatments will also be compared.	—

Measure

Time frame

Primary end point(s): 1. Total score on the Quick Inventory of Depressive Symptomatology, Clinician version QIDS-C16 at 12 weeks. 2. Time to (hypo)manic episode. ;Secondary Objective: Secondary objectives include the comparison of the three treatments in terms of continuing remission of depresssive symptoms, deliberate self-harm, unexpected adverse effects and mortality.; Main Objective: BALANCE 2 will compare the efficacy of SSRI, quetiapine and lamotrigine in the treatment of acute episodes of bipolar depression. SSRIs and quetiapine will each be compared to lamotrigine in terms of reduction of depressive symptoms at 12 weeks. Quetiapine and lamotrigine will each be compared to SSRIs in terms of risk or switch to mania. The costs, effects and cost-effectiveness of the three treatments will also be compared.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026