Phase 3 N=75 Randomized Double-blind Treatment

Treatment of Mania Symptoms With Drug Therapy

Bipolar Disorder · Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT00183443 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: Symptoms of Mania, as Measured by Young Mania Rating Scale — 5.7; 11.1; 10.0 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Divalproex-extended release (DVP-ER) (Drug); Lithium (Drug); Quetiapine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Palo Alto Veterans Institute for Research
Primary completion: Nov 2010

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	—

Summary

This study will determine the effectiveness of three different drug therapies in treating the symptoms of mania.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00183443). 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.