Zyprexa (Olanzapine) - Summary

ZYPREXA SUMMARY

ZYPREXA (olanzapine) is a psychotropic agent that belongs to the thienobenzodiazepine class.

ZYPREXA is indicated for the following:

SCHIZOPHRENIA

Oral ZYPREXA is indicated for the treatment of schizophrenia.

The efficacy of ZYPREXA was established in short-term (6-week) controlled trials of schizophrenic inpatients (see CLINICAL PHARMACOLOGY).

The effectiveness of oral ZYPREXA at maintaining a treatment response in schizophrenic patients who had been stable on ZYPREXA for approximately 8 weeks and were then followed for a period of up to 8 months has been demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use ZYPREXA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

BIPOLAR DISORDER

Acute Monotherapy -- Oral ZYPREXA is indicated for the treatment of acute mixed or manic episodes associated with Bipolar I Disorder.

The efficacy of ZYPREXA was established in two placebo-controlled trials (one 3-week and one 4-week) with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features (see CLINICAL PHARMACOLOGY).

Maintenance Monotherapy -- The benefit of maintaining bipolar patients on monotherapy with oral ZYPREXA after achieving a responder status for an average duration of two weeks was demonstrated in a controlled trial (see Clinical Efficacy Data under CLINICAL PHARMACOLOGY). The physician who elects to use ZYPREXA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Combination Therapy -- The combination of oral ZYPREXA with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.

The efficacy of ZYPREXA in combination with lithium or valproate was established in two placebo-controlled (6-week) trials with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features (see CLINICAL PHARMACOLOGY).

AGITATION ASSOCIATED WITH SCHIZOPHRENIA AND BIPOLAR I MANIA

ZYPREXA IntraMuscular is indicated for the treatment of agitation associated with schizophrenia and bipolar I mania. "Psychomotor agitation" is defined in DSM-IV as "excessive motor activity associated with a feeling of inner tension." Patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care, e.g., threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior, leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation.

The efficacy of ZYPREXA IntraMuscular for the treatment of agitation associated with schizophrenia and bipolar I mania was established in 3 short-term (24 hours) placebo-controlled trials in agitated inpatients with schizophrenia or Bipolar I Disorder (manic or mixed episodes) (see CLINICAL PHARMACOLOGY).

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NEWS HIGHLIGHTS

Media Articles Related to Zyprexa (Olanzapine)

FDA Advisory Committee Votes In Favor Of Zyprexa For Two Adolescent Indications
Source: Bipolar News From Medical News Today [2009.06.12]
The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted that Zyprexa(R) (olanzapine), an atypical antipsychotic, is effective and acceptably safe for the acute treatment of schizophrenia or manic or mixed episodes associated with bipolar I disorder in adolescents aged 13-17 years old.

Zyprexa in schizophrenia shown to prevent brain loss
Source: The Doctors Lounge - Psychiatry
Zyprexa (olanzapine) was found to decrease brain loss in schizophrenia patients according to the Archives of General Psychiatry.

Metabolic Effects Significantly Lower With INVEGA(R) Compared To Olanzapine
Source: Health News from Medical News Today [2009.11.19]
New data from a 6-month open label randomised controlled trial show INVEGA® (paliperidone ER) is associated with significantly less metabolic effects compared to oral olanzapine in people with schizophrenia, while demonstrating comparable efficacy.1 The results were presented at the 15th Biennial Winter Workshop in Psychoses in Barcelona, Spain.

Minimal Relationship Between Cannabis And Schizophrenia Or Psychosis Suggested By New UK Study
Source: Schizophrenia News From Medical News Today [2009.10.24]
Last year the UK government reclassified cannabis from a class C to a class B drug, partly out of concerns that cannabis, especially the more potent varieties, may increase the risk of schizophrenia in young people. But the evidence for the relationship between cannabis and schizophrenia or psychosis remains controversial. A new study has determined that it may be necessary to stop thousands of cannabis users in order to prevent a single case of schizophrenia.

Unlocking Mysteries Of The Brain With PET
Source: MRI / PET / Ultrasound News From Medical News Today [2009.11.04]
Inflammatory response of brain cells-as indicated by a molecular imaging technique-could tell researchers more about why certain neurologic disorders, such as migraine headaches and psychosis in schizophrenic patients, occur and provide insight into how to best treat them, according to two studies published in the November issue of The Journal of Nuclear Medicine.

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Published Studies Related to Zyprexa (Olanzapine)

Olanzapine-Divalproex combination versus divalproex monotherapy in the treatment of bipolar mixed episodes: a double-blind, placebo-controlled study. [2009.09.22]
CONCLUSION: Adjunctive olanzapine yielded greater and earlier reduction of manic and depressive symptoms in mixed-episode patients with inadequate response to at least 2 weeks of divalproex. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00402324. (c) Copyright 2009 Physicians Postgraduate Press, Inc.

A double-blind randomized controlled trial of olanzapine plus sertraline vs olanzapine plus placebo for psychotic depression: the study of pharmacotherapy of psychotic depression (STOP-PD). [2009.08]
CONTEXT: Evidence for the efficacy of combination pharmacotherapy has been limited and without positive trials in geriatric patients with major depression (MD) with psychotic features. OBJECTIVES: To compare remission rates of MD with psychotic features in those treated with a combination of atypical antipsychotic medication plus a serotonin reuptake inhibitor with those treated with antipsychotic monotherapy; and to compare response by age... CONCLUSIONS: Combination pharmacotherapy is efficacious for the treatment of MD with psychotic features. Future research must determine the benefits vs risks of continuing atypical antipsychotic medications beyond 12 weeks. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00056472.

Effectiveness and safety of the combination of fluoxetine and olanzapine in outpatients with bipolar depression: an open-label, randomized, flexible-dose study in Puerto Rico. [2009.08]
We studied the effectiveness of olanzapine/fluoxetine combination (OFC) treatment of bipolar depressive episode (7 weeks, study period 1 [SP1]). Study period 1 responders (mean modal daily OFC dosage, 10.8/27.8 mg) were randomized to OFC continuation treatment or olanzapine (OLZ) monotherapy starting at 10 mg (12 weeks, SP2)...

A randomized controlled trial of the effect of sublingual orally disintegrating olanzapine versus oral olanzapine on body mass index: the PLATYPUS Study. [2009.08]
BACKGROUND: Patients with schizophrenia and bipolar disorder have frequently reported weight gain during olanzapine treatment. Previous studies have observed a decrease in weight gain, or weight loss, in patients switching from standard olanzapine tablets (SOT) to orally disintegrating olanzapine (ODO) tablets. The primary objective of this study was to investigate the change in body mass index (BMI) in patients who had previously gained weight with SOT and continued with this therapy during the study period, compared with those patients who switched to ODO during the study period... CONCLUSIONS: In this study, patients treated with ODO experienced a similar mean change in BMI and weight from baseline, to those patients treated with SOT.

Olanzapine dosing above the licensed range is more efficacious than lower doses: fact or fiction? [2009.07]
A substantial number of patients with schizophrenia or bipolar disorder receive olanzapine in amounts that are greater than what is recommended in the product labeling approved by drug regulatory agencies. The purpose of this review is to describe the evidence supporting the use of olanzapine in excess of 20 mg/day...

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Clinical Trials Related to Zyprexa (Olanzapine)

Comparison of Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in Patients With Schizophrenia [Completed]
This is a randomized, double-blind study to determine how well intramuscular (IM) olanzapine depot works compared to oral olanzapine; evaluate the safety and tolerability of IM olanzapine depot compared to oral olanzapine; evaluate different doses of IM olanzapine depot; and determine the blood levels of IM olanzapine depot in patients at different points in time after an injection.

Effects of Modafinil on Olanzapine Weight Gain [Completed]
This study is designed as a 3 week, randomized, double blind, placebo controlled, trial. Olanzapine and modafinil will be titrated to 10mg and 200mg respectively. Feeding lab assessments will be conducted at baseline and endpoint. Assessments of hunger/satiety, kilocalories consumed and weight will be obtained. Plasma ghrelin and PYY3-36 levels will be drawn at baseline and endpoint prior to breakfast and two hours post.

Study hypothesis: The modafinil/olanzapine group will gain less weight than the olanzapine/placebo group over three weeks of drug intake.

Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia [Active, not recruiting]
To compare the health outcome of patients with schizophrenia, who are at risk for relapse, when treated with a long acting injection form of olanzapine versus treatment with oral olanzapine.

PET Imaging and Olanzapine Treatment in Borderline Personality Disorder [Active, not recruiting]
The overall design of the study is to perform both a PET and MRI scan on objectively identified borderline personality disorder patients, to treat them with olanzapine for 8 weeks, and to then re-scan the patients with PET.

Fasting Study of Olanzapine Tablets 20 mg and Zyprexa® Tablets 20 mg [Terminated]
The objective of this study was to investigate the bioequivalence of Mylan olanzapine 20 mg tablets to Eli Lilly Zyprexa® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.

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PATIENT REVIEWS / RATINGS / COMMENTS

Zyprexa review by 20 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		depression
Dosage & duration:		10mg taken every night for the period of six years
Other conditions:		anorexia nervosa
Other drugs taken:		Lamictal, birth control (Jolessa)
		Reported Results
Benefits:		Went from severely depressed before starting the medication to almost entirely free of depression a week after starting the medication; helped with insomnia.
Side effects:		drowsiness in the beginning, but I quickly got used to it.
Comments:		I entered a hospuital six years ago for suicidality; I wasn't sleeping, I wasn't eating (I had anorexia nervosa), and I was extremely depressed. I started taking 10mg of Zyprexa the first night I was there. I was really drowsy all the next day, but it waned over a few days (now it doesn't affect my energy level at all.) In about a week, my depression just lifted. This medicine has worked miracles for me- I've been depression-free since starting it- and I wouldn't go off it for any reason.

Zyprexa review by 38 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		schizophrenia
Dosage & duration:		27.5 mg taken daily for the period of 3 years
Other conditions:		None
Other drugs taken:		respiridone and lorazepam
		Reported Results
Benefits:		There was very little benefit to me. I was having psychotic episodes every day. The drug puportedly taken to stop the episodes did nothing. The best thing it did was make me drowsy and help me sleep.
Side effects:		The side effect mainly was weight gain, especially around the abdominal area. I've been on a medically supervised diet to lose the weight I gained from the drug and have lost weight but not around my abdomen, it seems the Olanzapine can cause this type of weight gain.
Comments:		I see a psychiatrist monthly. I have tried every drug recommended for Schizophrenia and none of the drugs have worked. I still have psychotic episodes.

Zyprexa review by 38 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		schizophrenia
Dosage & duration:		27.5 mg taken daily for the period of 3 years
Other conditions:		None
Other drugs taken:		respiridone and lorazepam
		Reported Results
Benefits:		There was very little benefit to me. I was having psychotic episodes every day. The drug puportedly taken to stop the episodes did nothing. The best thing it did was make me drowsy and help me sleep.
Side effects:		The side effect mainly was weight gain, especially around the abdominal area. I've been on a medically supervised diet to lose the weight I gained from the drug and have lost weight but not around my abdomen, it seems the Olanzapine can cause this type of weight gain.
Comments:		I see a psychiatrist monthly. I have tried every drug recommended for Schizophrenia and none of the drugs have worked. I still have psychotic episodes.