Phase 4
Completed N=112
Sequential Multiple Assignment Treatment for Bipolar Disorder
Bipolar I Disorder · Bipolar II Disorder
Source: ClinicalTrials.gov NCT01588457 ↗
Enrolled (actual)
112
Serious AEs
1.8%
Results posted
Aug 2020
Primary outcomePrimary: Bipolar Inventory of Symptoms Scale (BISS) — -0.31; -0.41; 0.15; -0.38 calculated mean scale score
◆ Published Evidence
Established
28citations · ~6 / year
Lamotrigine in the maintenance treatment of bipolar disorder.
Summary
The purpose of this study is to compare which of the two mood stabilizers (drugs that help to steady/stabilize mood in patients with bipolar disorder (BD)), lithium and divalproex, is more effective in patients with bipolar disorder over 26 weeks. The study will also compare if lithium or divalproex used alone versus lithium or divalproex used with quetiapine versus lithium or divalproex used with lamotrigine is more effective when symptoms of depression develop.
Linked Publications
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Lamotrigine in the maintenance treatment of bipolar disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bipolar Inventory of Symptoms Scale (BISS) |
-0.31; -0.41; 0.15; -0.38; -0.85; -0.71 | — |
| SECONDARY Global Assessment of Functioning |
-1.11; -0.32; -0.09; -0.99; -1.24; -0.69 | — |
| SECONDARY Baseline Randomization Percentage of Bipolar Types |
70; 74.1; 30; 25.9 | — |
| SECONDARY Demographic in Randomization 1 Group |
27.1; 33.3; 55.9; 37.0; 17.0; 29.6 | — |
Eligibility Criteria
Inclusion Criteria
- DSM-IV TR (Diagnostic and Statistical Manual Edition IV Text Revision) diagnosis BD I or II as assessed by MINI PLUS (Mini International Neuropsychiatric Interview PLUS)
- Male or female ≥ 18 years old
- Currently symptomatic with a CGI-BP-S ≥3 for mania/hypomania &/or depression for ≥ 2 weeks
- One of the following indicators of recent active illness: a depressive or manic or hypomanic or mixed episode in the past 12 months
- If female of child bearing age must use effective birth control.
Exclusion Criteria
- Unwilling or unable to comply with study requirements
- Renal impairment (serum creatinine > 1.5 mg/dL)
- If maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1
- Patients who have had intolerable side effects to QTP, Li, Div, or LTG
- Patients whose clinical status requires inpatient care
- Drug/alcohol dependence within the past 30 days
- Pregnancy as determined by serum pregnancy test or breastfeeding
- History of poor response to Li at a serum Li of ≥ 0.5 mEq/L (milliequivalents per Liter) or Div at a serum level of ≥ 45 mg/dL for at least 2 weeks.
Data sourced from ClinicalTrials.gov (NCT01588457) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.