Research and Clinical Trials on Olanzapine (Zyprexa)

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).

• Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects
  Status: Terminated, Condition Summary: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
• Olanzapine in Patients With Advanced Cancer and Weight Loss
  Status: Recruiting, Condition Summary: Advanced Cancer; Weight Loss
• IM Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia
  Status: Recruiting, Condition Summary: Schizophrenia; Schizoaffective Disorder; Agitation
• A 6 Month Study to Compare the Metabolic Effects of Paliperidone ER and Olanzapine in Patients With Schizophrenia.
  Status: Active, not recruiting, Condition Summary: Schizophrenia
• Olanzapine Treatment of Patients With Bipolar I Disorder
  Status: Recruiting, Condition Summary: Depression, Bipolar
• Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine
  Status: Completed, Condition Summary: Schizophrenia; Schizoaffective Disorders
• A Study of Zonisamide to Prevent Olanzapine-Associated Weight Gain
  Status: Recruiting, Condition Summary: Weight Gain
• Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder
  Status: Recruiting, Condition Summary: Manic or Mixed Episode Associated With Bipolar I Disorder
• Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine
  Status: Completed, Condition Summary: Bipolar Disorder I or II
• Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)
  Status: Completed, Condition Summary: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
• Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
  Status: Active, not recruiting, Condition Summary: Schizophrenic Disorders; Schizoaffective Disorder
• Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder
  Status: Completed, Condition Summary: Schizophrenia; Schizoaffective Disorder
• Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
  Status: Recruiting, Condition Summary: Bipolar Disorder
• Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia
  Status: Active, not recruiting, Condition Summary: Schizophrenia
• A New Pharmacotherapy for Alcohol Dependence: Olanzapine
  Status: Recruiting, Condition Summary: Alcohol Dependence

 

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Current Research Literature on Olanzapine (Zyprexa)

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

Characterization of the action of antipsychotic subtypes on valproate-induced chromatin remodeling.

Trends Pharmacol Sci. 2008 Dec 23;
Guidotti A, Dong E, Kundakovic M, Satta R, Grayson DR, Costa E
Recent advances in schizophrenia (SZ) research indicate that the telencephalic gamma-aminobutyric acid (GABA)ergic neurotransmission deficit associated with this psychiatric disorder probably is mediated by the hypermethylation of the glutamic acid decarboxylase 67 (GAD(67)), reelin and other GABAergic promoters. A pharmacological strategy to reduce the hypermethylation of GABAergic promoters is to induce a DNA-cytosine demethylation by altering the chromatin remodeling with valproate (VPA). When co-administered with VPA, the clinical efficacy of atypical antipsychotics is enhanced. This prompted us to investigate whether this increase in drug efficacy is related to a modification of GABAergic-promoter methylation via chromatin remodeling. Our previous and present results strongly indicate that VPA facilitates chromatin remodeling when it is associated with clozapine or sulpiride but not with haloperidol or olanzapine. This remodeling might contribute to reelin- and GAD(67)-promoter demethylation and might reverse the GABAergic-gene-expression downregulation associated with SZ morbidity.

Antipsychotic-induced body weight gain: Predictors and a systematic categorization of the long-term weight course.

J Psychiatr Res. 2008 Dec 23;
Gebhardt S, Haberhausen M, Heinzel-Gutenbrunner M, Gebhardt N, Remschmidt H, Krieg JC, Hebebrand J, Theisen FM
OBJECTIVE: To explore the impact of premorbid and baseline body mass indices (BMIs) as well as BMI of patient's parents and associated variables on the prediction of antipsychotic-induced body weight gain. METHODS: Retrospective/cross-sectional data of 65 patients receiving clozapine, olanzapine and/or risperidone were assessed according to a systematic categorization of the long-term (7.3+/-9.2 years) weight course and evaluated using descriptive, explorative correlation and regression analyses. RESULTS: Increased values of parents' BMI (p=0.041) and patients' BMI at premorbid stage (p=0.039) and prior to first antipsychotic treatment (p=0.032) as well as female gender (p=0.012), younger age (p=0.005) and non-smoking (p=0.047) have the most predictive value on body weight gain under antipsychotic treatment including pre-treatment with typical antipsychotics. Weight gain under atypical antipsychotics (pre-treatment excluded) is predicted by an increased premorbid BMI (p=0.019). Conversely, a low BMI prior to first antipsychotic treatment predicts a higher acceleration of BMI change (p=0.008) in vulnerable individuals, but not total BMI change itself. Furthermore, a diagnosis of a schizophrenia spectrum disorder showed a trend towards the prediction of an increased atypical DeltaBMI (p=0.067), possibly due to a longer treatment duration with atypical antipsychotics (p

The Role of Thermogenesis in Antipsychotic Drug-induced Weight Gain.

Obesity (Silver Spring). 2009 Jan; 17(1): 16-24
Stefanidis A, Verty AN, Allen AM, Owens NC, Cowley MA, Oldfield BJ
The administration of antipsychotic drugs to human patients or experimental animals leads to significant weight gain, which is widely presumed to be driven by hyperphagia; however, the contribution from energy expenditure remains unclear. These studies aim to examine the contribution of shifts in energy expenditure, particularly those involving centrally mediated changes in thermogenesis, to the body weight gain associated with the administration of olanzapine to female Sprague Dawley rats. Olanzapine (6 mg/kg/day orally) caused a transient increase in food intake but a maintained increase in body weight. When pair-fed rats were treated with olanzapine, body weight continued to rise compared to vehicle-treated rats, consistent with a reduction in energy expenditure. Brown adipose tissue (BAT) temperature, measured using biotelemetry devices, decreased immediately after the onset of olanzapine treatment and remained depressed, as did physical activity. UCP1 expression in interscapular BAT was reduced following chronic olanzapine treatment. An acute injection of olanzapine was preceded by an injection of a retrograde tracer into the spinal cord to evaluate the nature of the olanzapine-activated neural pathway. Levels of Fos protein in a number of spinally projecting neurons within discrete hypothalamic and brainstem sites were elevated in olanzapine-treated rats. Some of these neurons in the perifornical region of the lateral hypothalamus (LHA) were also Orexin A positive. These data collectively show a significant impact of thermogenesis (and physical activity) on the weight gain associated with olanzapine treatment. The anatomical studies provide an insight into the central neuroanatomical substrate that may subserve the altered thermogenic responses brought about by olanzapine.Obesity (2008) 17 1, 16-24. doi:10.1038/oby.2008.468.

Dose trends for second-generation antipsychotic treatment of schizophrenia and bipolar disorder.

Schizophr Res. 2008 Dec 22;
Citrome L, Reist C, Palmer L, Montejano L, Lenhart G, Cuffel B, Harnett J, Sanders KN
BACKGROUND: Antipsychotic dosing used in clinical practice can differ from dosing originally recommended in product labeling. This has been reported for olanzapine and quetiapine, where higher doses are commonly used. This may be the case for ziprasidone as well. METHOD: To characterize changes over time in dosing for the initial and subsequent prescriptions of first-line second-generation antipsychotics used during treatment episodes for outpatients with schizophrenia and bipolar disorder, the 2001-2005 Thomson MarketScan Medicaid Database (Medicaid) and the 2001-2006 MarketScan Commercial Claims and Encounters Database (Commercial) were analyzed. Dose trends were evaluated using autoregressive time-series models. RESULTS: Data were available for 49180 treatment episodes of schizophrenia (4683 Commercial and 44497 Medicaid) and 83289 treatment episodes of bipolar disorder (57961 Commercial and 25328 Medicaid). The initial prescription mean daily and overall mean daily doses of ziprasidone in schizophrenia episodes significantly increased across the Medicaid and Commercial populations, with similar trends observed for bipolar episodes. The first (May 2001) and last (December 2005) observed 3-month mean daily doses for ziprasidone were 112 mg/d and 138 mg/d for patients with schizophrenia and 93 mg/d and 113 mg/d for those with bipolar disorder in the Medicaid cohort, with similar findings for the Commercial cohort. Consistently significant trends in dose changes were not observed for the other medications, although quetiapine and olanzapine doses generally increased while aripiprazole and risperidone doses generally decreased. CONCLUSIONS: There remains a need for controlled randomized clinical trials that test fixed doses of antipsychotics to ascertain the dose-response relationship within the dose range used in contemporary clinical practice.

An Exploration of the Effect of Modafinil on Olanzapine Associated Weight Gain in Normal Human Subjects.

Biol Psychiatry. 2008 Dec 20;
Roerig JL, Steffen KJ, Mitchell JE, Crosby RD, Gosnell BA
BACKGROUND: Weight gain has been associated with many second generation antipsychotics (SGAs). A variety of theories have been put forward as to the etiology of SGA-associated weight gain. Modafinil possesses pharmacologic effects that could influence the weight gain associated with SGAs. The objective of this trial was to determine the effect of modafinil on olanzapine-associated weight gain. METHODS: This study was a 3-week, randomized, double-blind, placebo-controlled trial. All subjects received olanzapine titrated to 10 mg/day. Concurrently, subjects were randomized to receive modafinil titrated to 200 mg/day or placebo. Weight and feeding lab assessments were conducted at baseline and endpoint. RESULTS: Fifty subjects were enrolled in the study with 20 subjects per group completing the trial. The primary outcome variable was change in the body mass index (BMI) over the 3 weeks of the trial. Increases in BMI were observed in both groups. However, analysis of covariance, controlled for baseline BMI, revealed that the olanzapine/placebo group had a greater increase in BMI at end point compared with the olanzapine/modafinil group (.89 +/- .59 vs. .47 +/- .50 kg/m(2), p < .05). When controlled for gender, the comparison showed a significant difference between groups at week 1 but not at weeks 2 or 3. CONCLUSIONS: The results of this trial should not be extrapolated to clinical practice at this time. These data do serve to support further evaluation in a patient population to determine if the weight modifying effect of modafinil can be demonstrated over a longer period of time.