Phase 3
Completed N=75
Treatment of Mania Symptoms With Drug Therapy
Source: ClinicalTrials.gov NCT00183443 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Symptoms of Mania, as Measured by Young Mania Rating Scale — 5.7; 11.1; 10.0 units on a scale
◆ Published Evidence
Not yet cited
0citations
A pilot trial of quetiapine, lithium, or placebo added to divalproex sodium for hypomanic or manic episodes in ambulatory adults with bipolar I disorder.
Summary
This study will determine the effectiveness of three different drug therapies in treating the symptoms of mania.
Linked Publications
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A pilot trial of quetiapine, lithium, or placebo added to divalproex sodium for hypomanic or manic episodes in ambulatory adults with bipolar I disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptoms of Mania, as Measured by Young Mania Rating Scale |
5.7; 11.1; 10.0 | — |
| SECONDARY Hamilton Rating Scale for Depression (HAM-D,17) |
13.2; 18.3; 18.8 | — |
| SECONDARY Clinical Global Impression Scale for Bipolar Disorder (CGI-BD) |
1.58; 2.54; 2.32 | — |
| SECONDARY Global Assessment of Functioning |
68.3; 62.3; 60.8 | — |
| SECONDARY Social and Occupational Functioning Assessment Scale (SOFAS) |
68.2; 62.1; 59.8 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of bipolar I disorder or schizophrenia
- Experiencing symptoms of mania at study entry
- Able to speak and understand English
- Willing and able to comply with all study requirements
Exclusion Criteria
- History of partial response or nonresponse to any of the drugs or drug combinations given in this study
- History of intolerance to DVP, DVP-ER, lithium, or quetiapine
- Disorders that would contraindicate the use of DV, DV-ER, lithium, or quetiapine
- Use of antidepressants within 1 month prior to study entry
- Use of fluoxetine within 3 months prior to study entry
- Impaired cardiac function, as evidenced by abnormal EKG in participants 50 or over
- Unstable medical illness within 2 months prior to study entry
- At risk for suicide
- Substance abuse or dependence within 1 month prior to study entry
- Pregnancy, breastfeeding, or plans to become pregnant during the study
Data sourced from ClinicalTrials.gov (NCT00183443) 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.