Olanzapine plus fluoxetine demonstrated superior efficacy for treating resistant depression compared to either agent alone.

Background: A 6-week double-blind, randomized, placebo-controlled trial was conducted to determine the efficacy of combined therapy with olanzapine and either valproate or lithium compared with valproate or lithium alone in treating acute manic or mixed bipolar episodes.Methods: The primary objective was to evaluate the efficacy of olanzapine (5-20 mg/d) vs placebo when added to ongoing mood-stabilizer therapy as measured by reductions in Young Mania Rating Scale (YMRS) scores. Patients with bipolar disorder (n = 344), manic or mixed episode, who were inadequately responsive to more than 2 weeks of lithium or valproate therapy, were randomized to receive cotherapy (olanzapine + moodstabilizer) or monotherapy (placebo + mood-stabilizer).Results: Olanzapine cotherapy improved patients' YMRS total scores significantly more than monotherapy (−13.11 vs −9.10; P=.003). Clinical response rates (Ն50% improvement on YMRS) were significantly higher with cotherapy (67.7% vs 44.7%; PϽ.001). Olanzapine cotherapy im-proved 21-item Hamilton Depression Rating Scale (HAMD-21) total scores significantly more than monotherapy (4.98 vs 0.89 points; PϽ.001). In patients with mixed-episodes with moderate to severe depressive symptoms (DSM-IV mixed episode; HAMD-21 score of Ն20 at baseline), olanzapine cotherapy improved HAMD-21 scores by 10.31 points compared with 1.57 for monotherapy (PϽ.001). Extrapyramidal symptoms (Simpson-Angus Scale, Barnes Akathisia Scale, Abnormal Involuntary Movement Scale) were not significantly changed from baseline to end point in either treatment group. Treatment-emergent symptoms that were significantly higher for the olanzapine cotherapy group included somnolence, dry mouth, weight gain, increased appetite, tremor, and slurred speech. Conclusion:Compared with the use of valproate or lithium alone, the addition of olanzapine provided superior efficacy in the treatment of manic and mixed bipolar episodes.

Patients taking olanzapine added to lithium or valproate experienced sustained symptomatic remission, but not syndromic remission, for longer than those receiving lithium or valproate monotherapy.

While 1.0 mg olanzapine did not show significant differences from placebo, the 2.5 mg dose was a reasonable starting dose. Olanzapine at 7.5 mg/day significantly decreased psychosis and overall behavioral disturbances (NPI/NH, BPRS) and was well tolerated.

This double-blind study investigated the efficacy and safety of rapid-acting intramuscular olanzapine in treating agitation associated with Alzheimer's disease and/or vascular dementia. At 2 h, olanzapine (5.0 mg, 2.5 mg) and lorazepam (1.0 mg) showed significant improvement over placebo on the PANSS Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES),It has been estimated that 5% of people older than 65, and up to 20% of those aged 80 and older, are affected by dementia (Gurland and Cross 1982;Small and Jarvik 1982). Of these, nearly half exhibit behavioral disturbances, such as agitation, wandering, and violent outbursts (Kunik et al. 1994). Agitation has been defined as "inappropriate verbal, vocal, or motor activity not explainable by apparent needs or confusion" (CohenMansfield 1986), and includes both physically and verbally aggressive behaviors such as hitting, biting, and From the Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana (KMM, HW, SRD, JRN, BJ, CMB, PDF, AB), Institute of Psychiatry, Medical University of South Carolina, Charleston, South Carolina (JEM), and Senior Choice Unit, Presbyterian Hospital, Oklahoma City, Oklahoma (LMB).Address correspondence to: Dr. Alan Breier, Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, Tel.: (317) Fax: (317) 433-5101. Received February 12, 2001; revised May 23, 2001; accepted September 7, 2001.Online publication: 9/13/01 at www.acnp.org/citations/Npp 091301174.N EUROPSYCHOPHARMACOLOGY 2002 -VOL . 26 , NO . 4 Rapidly Acting IM Olanzapine in Dementia 495 screaming, and nonaggressive behaviors such as pacing, wandering, and continual requests for attention. In nursing home patients with dementia, the prevalence of these disturbances may be as high as 75% (Deutsch and Rovner 1991). Severe symptoms of agitation may require rapid treatment in the form of parenteral medication when a very rapid onset is required or when patients refuse or cannot take oral agents. In some instances, the use of medication is less desirable than alternative methods such as behavioral intervention. However, occasions arise where a pharmacological intervention is unavoidable and in the best interests of the patient. Lorazepam is commonly used for treatment of acute agitation, and the benzodiazepines are currently among the few agents available in a parenteral formulation for treatment of agitation. Use of orally administered atypical antipsychotics such as olanzapine and risperidone has met with some success in treating behavioral disturbances in patients with dementia (Clark et al. 2001;De Deyn et al. 1999;Katz et al. 1999;Street et al. 2000). A parenteral formulation of a second-generation antipsychotic might offer some advantage over their corresponding oral formulations due to faster onset of effect and utility where the patient cannot, or will not, accept oral treatment (Bianchetti et al. 1980;Schaffer et al. 1982). Rapid tranquilization with parenteral...

Atomoxetine did not exacerbate tic symptoms. Rather, there was some evidence of reduction in tic severity with a significant reduction of attention deficit/hyperactivity disorder symptoms. Atomoxetine treatment appeared safe and well tolerated.

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