ABSTRACT
OBJECTIVE: This study compared the efficacy and safety of paroxetine and imipramine with that of placebo in the treatment of bipolar depression in adult outpatients stabilized on a regimen of lithium. METHOD: In a double-blind, placebo-controlled study, 117 outpatients with DSM-III-R bipolar disorder, depressive phase, were randomly assigned to treatment with paroxetine (N=35), imipramine (N=39), or placebo (N=43) for 10 weeks. In addition to lithium monotherapy, patients may have received either carbamazepine or valproate in combination with lithium for control of manic symptoms. Patients were stratified on the basis of trough serum lithium levels determined at the screening visit (high: >0.8 meq/liter; low:
Subject(s)
Antidepressive Agents, Tricyclic/therapeutic use , Bipolar Disorder/drug therapy , Imipramine/therapeutic use , Paroxetine/therapeutic use , Selective Serotonin Reuptake Inhibitors/therapeutic use , Adult , Aged , Ambulatory Care , Anticonvulsants/therapeutic use , Bipolar Disorder/psychology , Carbamazepine/therapeutic use , Double-Blind Method , Drug Therapy, Combination , Female , Humans , Lithium/therapeutic use , Male , Middle Aged , Placebos , Treatment Outcome , Valproic Acid/therapeutic useABSTRACT
OBJECTIVE: This study was designed to determine the minimum paroxetine dose effective for treating panic disorder. METHOD: Of 425 patients with DSM-III-R panic disorder with or without agoraphobia who underwent a 2-week drug-free screening period, 278 patients were randomly assigned to double-blind treatment with a 10-week course of placebo or paroxetine at a dose of 10, 20, or 40 mg/day. RESULTS: At 40 mg/day, paroxetine was superior to placebo across the majority of outcome measures. Despite a mean of 9.5 to 11.6 full panic attacks during the screening period, 86.0% of the patients taking 40 mg of paroxetine, 65.2% of those taking 20 mg, 67.4% of those taking 10 mg, and 50.0% of the placebo-treated patients were free of full panic attacks during the 2 weeks ending at week 10. The 40-mg paroxetine group experienced significantly greater global improvement than the placebo group and significantly greater improvement in frequency of full and limited-symptom panic attacks, intensity of full panic attacks, phobic fear, anxiety, and depressive symptoms, usually evident by week 4. All doses of paroxetine were well tolerated, and adverse effects were consistent with those associated with selective serotonin reuptake inhibitors. CONCLUSIONS: Paroxetine is an effective and well-tolerated short-term treatment of panic disorder. The minimum dose demonstrated to be significantly superior to placebo was 40 mg/day, although some patients did respond at lower doses.
