Research and Clinical Trials on Olanzapine (Zyprexa)

avatar image
By Dr Greg Mulhauser

This list of current clinical research trials on Olanzapine (Zyprexa) is followed by a short set of abstracts from the most recent research articles published on the drug.

Article Contents

Olanzapine (Zyprexa) Clinical Research Trials

From our searchable database at ClinicalTrialsFeeds.org, this list includes all the latest information about clinical trials involving Olanzapine (Zyprexa).

 

Get These Clinical Trials as a Newsfeed

Olanzapine:     Get the Olanzapine clinical trials feed.    Add the Olanzapine clinical trials feed to your My Yahoo! page.    Add the Olanzapine clinical trials feed to your MyMSN page.

Current Research Literature on Olanzapine (Zyprexa)

Here are abstracts for some of the latest research articles to have appeared on Olanzapine (Zyprexa):

Lack of effect of stimulant combination with second-generation antipsychotics on weight gain, metabolic changes, prolactin levels, and sedation in youth with clinically relevant aggression or oppositionality.

J Child Adolesc Psychopharmacol. 2009 Oct; 19(5): 563-73
Penzner JB, Dudas M, Saito E, Olshanskiy V, Parikh UH, Kapoor S, Chekuri R, Gadaleta D, Avedon J, Sheridan EM, Randell J, Malhotra AK, Kane JM, Correll CU
BACKGROUND: Second-generation antipsychotics (SGAs) are associated with weight gain, metabolic abnormalities, sedation/sleep disturbance, and prolactin abnormalities, especially in youths. Although stimulants have opposing dopamine receptor and adverse effects, it is unclear whether stimulant co-treatment counteracts the therapeutic or side effects of antipsychotics. METHODS: This was a naturalistic cohort study including 153 antipsychotic trials in youths aged 4-19 (mean, 11.3 +/- 3.0) years, started on an SGA for clinically significant aggression or oppositionality associated with oppositional defiant disorder, conduct disorder, disruptive behavior disorder not otherwise specified (NOS), impulse control disorder NOS, intermittent explosive disorder, Tourette's disorder, autistic disorder, and pervasive developmental disorder NOS. Patients underwent fasting assessments of body composition, lipids, glucose, insulin, prolactin, sedation, and general efficacy at baseline, weeks 4, 8, and 12, comparing patients co-prescribed stimulants (n = 71) with those not co-prescribed stimulants (n = 82). RESULTS: Patients received risperidone (33.3%), aripiprazole (29.4%), quetiapine (18.4%), olanzapine (11.8%), ziprasidone (5.9%), or clozapine (0.7%). With and without adjustment for differences in baseline variables (sex, prior stimulant use, primary Diagnostic and Statistical Manual of Mental Disorders, 4(th) edition [DSM-IV] disorders, co-morbid attention-deficit/hyperactivity disorder [ADHD], present in 46.3% of youths not receiving stimulants, and some body composition parameters), patients on versus off stimulants did not differ on any of the assessed outcomes (all p values > or = 0.1). CONCLUSIONS: In contrast to guidelines, stimulant use did not precede or accompany antipsychotic use during the current episode of aggression/oppositionality in almost half of those youths who had aggressive/oppositional behavior and a DSM-IV diagnosis of ADHD. At the clinically prescribed doses, stimulant co-treatment of SGAs did not seem to significantly reduce antipsychotic effects on body composition, metabolic parameters, prolactin, sedation, and broad efficacy.

Comparison of open-label, 8-week trials of olanzapine monotherapy and topiramate augmentation of olanzapine for the treatment of pediatric bipolar disorder.

J Child Adolesc Psychopharmacol. 2009 Oct; 19(5): 539-45
Wozniak J, Mick E, Waxmonsky J, Kotarski M, Hantsoo L, Biederman J
BACKGROUND: The aim of this study was to test the efficacy and safety of olanzapine + topiramate versus olanzapine monotherapy in the treatment of bipolar disorder (BPD) and treatment-attendant weight gain in children and adolescents. METHOD: Subjects (N = 40) were outpatients of both sexes, 6-17 years of age, with a Diagnostic and Statistical Manual of Mental Disorders, 4(th) edition (DSM-IV) diagnosis of BPD (manic, hypomanic, or mixed) and Young Mania Rating Scale (YMRS) total score of >15 treated over 8-week periods in two partially concurrent open-label trials with olanzapine (n = 17) or olanzapine + topiramate (n = 23). RESULTS: Subjects in both groups experienced a statistically significant reduction in YMRS scores after 8-week, open-label treatment with olanzapine (baseline YMRS = 26.7 +/- 9.5; end-point YMRS = 18.2 +/- 12.5, p = 0.04) and olanzapine +topiramate (baseline YMRS = 31.3 +/- 7.9; end-point YMRS = 20.4 +/- 11.4, p = 0.04). There was no difference in response between the two groups based on YMRS or Clinical Global Impressions-Improvement (CGI-I) scores. Adverse events were few and mild and similar between the two groups, with the exception of weight gain. The weight gain in the olanzapine group was 5.3 +/- 2.1 kg and the weight gain in the olanzapine + topiramate group was statistically significantly lower, 2.6 +/- 3.6 kg. CONCLUSIONS: Augmentation of olanzapine with topiramate resulted in a reduced weight gain over the course of an 8-week, open-label trial when compared with olanzapine treatment alone, but did not lead to greater reduction in symptoms of mania.

Effect of Valproate on Olanzapine Plasma Concentrations in Patients With Bipolar or Schizoaffective Disorder.

Ther Drug Monit. 2009 Oct 27;
Spina E, Dʼarrigo C, Santoro V, Rosaria Muscatello M, Pandolfo G, Zoccali R, Diaz FJ, de Leon J
The effect of valproate on the steady-state plasma concentrations of olanzapine was investigated in 18 patients with bipolar or schizoaffective disorder. Additional valproate, at a dose ranging from 600 to 2000 mg/d, was administered for 4 weeks to patients stabilized on olanzapine (5-20 mg/d). During valproate coadministration, mean plasma olanzapine concentrations decreased significantly from 32.9 +/- 9.7 ng/mL at baseline to 27.4 +/- 9.8 ng/mL at week 2 (P = 0.02), and to 26.9 +/- 9.2 ng/mL at week 4 (P = 0.001). Smoking also decreased plasma olanzapine concentrations. Valproate coadministration with olanzapine was well tolerated and no patient showed a worsening of his or her psychopathological condition. These findings indicate that valproate, at doses of up to 2000 mg/d, is associated with a minimal, presumably not clinically significant, decrease in plasma olanzapine concentrations, possibly as a result of induction of olanzapine metabolism. New studies are needed to confirm that valproate could have mild inductive effects.

Attenuation of phencyclidine-induced object recognition deficits by the combination of atypical antipsychotic drugs with pimavanserin (ACP 103), a 5-hydroxytryptamine2A receptor inverse agonist.

J Pharmacol Exp Ther. 2009 Oct 28;
Snigdha S, Horiguchi M, Li Z, Huang M, Shahid M, Neill JC, Meltzer HY
Sub-chronic administration of the NMDA receptor antagonist, phencyclidine (PCP), in rodents has been shown to produce impairment in novel object recognition (NOR), a model of visual learning and memory. We tested the hypothesis that the selective 5-HT(2A) inverse agonists, pimavanserin and M10097, would potentiate sub-effective doses of atypical antipsychotic drugs (APDs) to reverse the NOR deficits. Methods: Female rats received vehicle or PCP (2 mg/kg bid) for 7 days, followed by 7 day washout. Pimavanserin (3 mg/kg) or M100907 (1 mg/kg) alone, or four atypicial APDs, risperidone (0.05-0.1 mg/kg), melperone (1-3 mg/kg), olanzapine (1-2 mg/kg), or N-desmethylclozapine (1-2 mg/kg), and the typical APD, haloperidol (0.05 -0.1 mg/kg), were adminstered alone, or in combination with pimavanserin or M100907, prior to NOR testing. The exploration times of objects during 3 min acquisition and retention trials, separated by a 1 min interval, were compared by ANOVA. Results: Vehicle-, but not PCP-treated, animals, explored the novel object significantly more than the familiar, in the retention trial (p

Impact of antipsychotic medication on family burden in schizophrenia: Longitudinal results of CATIE trial.

Schizophr Res. 2009 Oct 27;
Perlick DA, Rosenheck RA, Kaczynski R, Swartz MS, Canive JM, Lieberman JA
BACKGROUND: This study evaluated the effectiveness of first- and second-generation antipsychotics in reducing family burden associated with schizophrenia. METHODS: The family caregivers of 623 SCID-diagnosed patients enrolled in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) randomly assigned to a first-generation antipsychotic (perphenazine) or one of four second-generation drugs (olanzapine, quetiapine, risperidone or ziprasidone) were interviewed about resources provided and stresses experienced at baseline and followed for 18months. Patient symptoms, side effects and service use were assessed as well. Hierarchical regression analyses evaluated the effect of treatment assignment on four burden factors: problem behavior, resource demands and disruption, impairment in activities of daily living and patient helpfulness. Intention-to-treat analyses with all available observations classified based on initial treatment assignment, including observations after medications changed were followed by secondary analyses excluding observations after the first medication change, i.e. only considering initial medication. RESULTS: Despite significant reductions on the problem behavior and resource demands/disruption factors, there were no significant differences between perphenazine and any of the second-generation medications. When only initial treatment period observations were included, patients were perceived as more helpful when medicated with perphenazine as compared to risperidone. In comparisons between second-generation drugs, patients on quetiapine were perceived as more helpful than those on risperidone (p=0.004). CONCLUSION: In this 18-month randomized trial, there was no evidence of superiority of second-generation antipsychotics in relieving family burden.

 

This page was last reviewed by Dr Greg Mulhauser, Monday, 1 June 2009.

The URL of this page is:
http://counsellingresource.com/medications/trials-and-research/olanzapine-research.html