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Table 1 Inclusion and exclusion criteria

From: A pilot trial of quetiapine, lithium, or placebo added to divalproex sodium for hypomanic or manic episodes in ambulatory adults with bipolar I disorder

Inclusion criteria

Exclusion criteria

• English-speaking adults at least 18 years old

• History of DSM-IV bipolar I disorder, confirmed by Structured Clinical Interview

• Experiencing hypomania or mania with a score on Young Mania Rating Scale ≥ 15 and meeting DSM-IV criteria for a current hypomanic, manic, or mixed episode

• Desire to seek treatment for bipolar I disorder

• Written informed consent obtained and willingness to perform study procedures confirmed

• Agree to taper existing ineffective medications and be randomized to one of the three study conditions

• No use of antidepressants for 1 month prior to randomization (3 months for fluoxetine)

• Patients who are euthymic (well) on their current medications

• Patients who are already taking combination DVP + Li or DVP + QTP

• Patients with a history of partial or nonresponse to DVP, Li, QTP, or any combination of those medications, documented by serum levels

• History of intolerance or toxicity to DVP, Li, or QTP

• History of adverse experiences to DVP, Li, or QTP

• Disorders that would contraindicate or limit the use of Li, including dermatological conditions, such as psoriasis or acne vulgaris, or kidney failure

• Disorders that would contraindicate the use of DVP, including clinically significant active hepatitis or hepatic failure as evidenced by abnormal laboratory values

• Impaired cardiac function as evidenced by positive EKG in subjects age 50 or over

• Patients with unstable medical illnesses within the past 2 months

• Current suicidal ideation or intent

• Substance abuse or dependency within the past month

• Pregnant (i.e., positive urine pregnancy test) or nursing women or planning to conceive