Phase 4
Completed N=224
Treatment of Bipolar Mania in Older Adults
Source: ClinicalTrials.gov NCT00254488 ↗Enrolled (actual)
224
Serious AEs
20.5%
Results posted
Aug 2018
Primary outcomePrimary: Sedation Score — 0.5; 0.5; 0.6; 0.6 units on a scale
◆ Published Evidence
Established
37citations · ~2 / year
Conceptual and methodological issues in designing a randomized, controlled treatment trial for geriatric bipolar disorder: GERI-BD.
Summary
This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.
Linked Publications (5)
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Conceptual and methodological issues in designing a randomized, controlled treatment trial for geriatric bipolar disorder: GERI-BD.
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The relationship of bipolar disorder lifetime duration and vascular burden to cognition in older adults.
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Characteristics associated with inpatient versus outpatient status in older adults with bipolar disorder.
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Social support in late life mania: GERI-BD.
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Depression symptom ratings in geriatric patients with bipolar mania.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sedation Score |
0.5; 0.5; 0.6; 0.6; 0.4; 0.5 | — |
| PRIMARY Young Mania Rating Scale (YMRS) Scores |
21.4; 19.7; 19.0; 16.3; 14.3; 15.2 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of DSM-IV Bipolar Disorder, Type I: current manic, mixed, or hypomanic episodes
Exclusion Criteria
- Rapid cycling bipolar disorder
- History of substance abuse or dependence within last 3 months
- Diagnosis of schizophrenia or other chronic psychotic conditions
- Acute or unstable medical illness
- Documented intolerance to Lithium, Depakote, Risperidone, or Lorazepam
- Dementia
- Inability to communicate in English
Data sourced from ClinicalTrials.gov (NCT00254488) 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.