Phase 4
Completed N=283
Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder
Source: ClinicalTrials.gov NCT00667745 ↗Enrolled (actual)
283
Serious AEs
9.2%
Results posted
Jun 2013
Primary outcomePrimary: Overall Change in Bipolar Illness Severity as Measured by Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Score — -1.22; -1.48 units on a scale — p=0.33
Summary
This study evaluated whether lithium included as part of optimized medication treatment improved overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Change in Bipolar Illness Severity as Measured by Clinical Global Impression for Bipolar Disorder Severity (CGI-BP-S) Score |
-1.22; -1.48 | 0.33 |
| PRIMARY Number of Necessary Medication Adjustments |
1.17; 1.26 | 0.967 |
| SECONDARY Depression Symptoms as Measured Self Report Montgomery Asberg Depression Rating Scale (MADRS) |
8.20; 8.84 | 0.50 |
| SECONDARY Mania Symptoms as Measured by the Young Mania Rating Scale (YMRS) |
6.35; 5.79 | 0.88 |
| SECONDARY Suicidality as Measured by the Modified Scale for Suicidal Ideation (MSSI) |
0.73; 1.10 | .49 |
Eligibility Criteria
Inclusion Criteria
- Meets DSM-IV Criteria for bipolar disorder (type I or II)
- Currently symptomatic, as defined as a Clinical Global Impressions Scale-Bipolar Version, Overall Severity Index (CGI-BP-S) of greater than or equal to 3
- If taking or has taken lithium, must be off lithium for at least 30 days before study entry
- If a woman of child bearing potential, agrees to inform their doctor at the earliest possible time of their plans to conceive, to use adequate contraception (e.g. oral contraceptives, intrauterine device, barrier methods, total abstinence from intercourse), and to acknowledge the risks of lithium to the fetus and infant (Depo Provera is acceptable if it is started 3 months before study entry)
Exclusion Criteria
- Renal impairment (serum creatinine greater than 1.5 mg/dL)
- Thyroid stimulating hormone (TSH) over 20% above the upper normal limit (participants maintained on thyroid medication must be euthyroid for at least 3 months before Visit 1)
- History of lithium toxicity that was not caused by mismanagement or overdose
- Other contraindication to lithium (e.g., hypersensitivity to lithium or any component of the formulation, severe cardiovascular or renal disease, severe debilitation, dehydration, sodium depletion, pregnancy)
- Currently in crisis such that inpatient hospitalization or other crisis - Participated in a clinical trial of an investigational drug within the 1 months before study entry
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00667745). 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.