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).

See all Zyprexa indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zyprexa (Olanzapine)

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.

Early Cognitive Behavioural Therapy Reduces Risk Of Psychosis
Source: Mental Health News From Medical News Today [2013.04.23]
Young people seeking help who are at high risk of developing psychosis could significantly reduce their chances of going on to develop a full-blown psychotic illness by getting early access to cognitive behavioural therapy (CBT), new research shows...

In The Brain High Levels Of Glutamate May Kick-Start Schizophrenia
Source: Anxiety / Stress News From Medical News Today [2013.04.22]
An excess of the brain neurotransmitter glutamate may cause a transition to psychosis in people who are at risk for schizophrenia, reports a study from investigators at Columbia University Medical Center (CUMC) published in the current issue of Neuron...

New Gene Variant May Explain Psychotic Features In Bipolar Disorder
Source: Bipolar News From Medical News Today [2013.03.06]
Researchers at Karolinska Institutet in Sweden have found an explanation for why the level of kynurenic acid (KYNA) is higher in the brains of people with schizophrenia or bipolar disease with psychosis. The study, which is published in the scientific periodical Molecular Psychiatry, identifies a gene variant associated with an increased production of KYNA...

more news >>

Published Studies Related to Zyprexa (Olanzapine)

Association of common variations in the norepinephrine transporter gene with response to olanzapine-fluoxetine combination versus continued-fluoxetine treatment in patients with treatment-resistant depression: a candidate gene analysis. [2012]
CONCLUSIONS: Our findings further support the hypothesis that the synergistic

Factors associated with non-completion in a double-blind randomized controlled trial of olanzapine plus sertraline versus olanzapine plus placebo for psychotic depression. [2012]
High rates of attrition have been reported in randomized controlled trials of patients with severe psychiatric illness, including psychotic depression (MDpsy). The purpose of this study is to examine factors associated with overall attrition and with subtypes of attrition in the Study of the Pharmacotherapy of Psychotic Depression (STOP-PD).

Efficacy and safety of olanzapine in the treatment of Japanese patients with bipolar I disorder in a current manic or mixed episode: a randomized, double-blind, placebo- and haloperidol-controlled study. [2012]
manic/mixed episode... CONCLUSIONS: This was the first study to evaluate an atypical antipsychotic in

Risperidone and olanzapine versus another first generation antipsychotic in patients with schizophrenia inadequately responsive to first generation antipsychotics. [2012]
CONCLUSIONS: Haloperidol or trifluoperazine demonstrated similar efficacy as

A dose comparison of olanzapine for the treatment of borderline personality disorder: a 12-week randomized, double-blind, placebo-controlled study. [2011.10]
CONCLUSIONS: Olanzapine 5-10 mg/d showed a clinically modest advantage over placebo in the treatment of overall borderline psychopathology. This advantage in effectiveness should be weighed against the risk of adverse events (particularly weight gain), which were consistent with the known safety profile of olanzapine. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00088036. (c) Copyright 2011 Physicians Postgraduate Press, Inc.

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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.

Augmenting Zyprexa With Naltrexone to Ameliorate Metabolic Side-Effects [Recruiting]
The main purpose of this study is to determine whether the opioid antagonist naltrexone is helpful in ameliorating the weight gain and other adverse metabolic side effects experienced by schizophrenic patients taking the second generation antipsychotic (SGA) Zyprexa. Schizophrenics may have an altered/enhanced endogenous opioidergic drive, and because of this, normally painful stimuli will be sensed as less painful in schizophrenics vs. healthy controls. A secondary hypothesis for this study is that naltrexone augmentation of Zyprexa will normalize subjective pain ratings. Our tertiary objective is to examine the safety and tolerability of naltrexone in Zyprexa-treated patients with schizophrenia.

Comparison of Antipsychotic Combination Treatment of Olanzapine and Amisulpride to Monotherapy [Recruiting]
A study to examine whether an antipsychotic combination treatment of olanzapine and amisulpride is more effective than olanzapine and amisulpride alone.

more trials >>

Reports of Suspected Zyprexa (Olanzapine) Side Effects

Weight Increased (199),  OFF Label USE (147),  Overdose (142),  Diabetes Mellitus (117),  Hospitalisation (77),  Confusional State (68),  Hypertension (68),  Death (67),  Somnolence (66),  Pneumonia (61), more >>

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 care giver of 81 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		agitation management r/t Lewy Body Syndrome Demen
Dosage & duration:		20mg taken x1 / daily for the period of 5 years
Other conditions:		B/P ,Diabetes, obesity, SVT's,osteoporosis
Other drugs taken:		ASA, Cardia, Fosamax, glyburide,Lorazepam, Metformin, Namenda,Razadyne, Simvastatin, Zetia, Plavix
		Reported Results
Benefits:		The Zyprexa minimized agitative outbursts
Side effects:		The pt developed severe "gait freezing" , gait shuffling, severe muscle weakness, and gereral stupor
Comments:		Since many of these s/s are also s/s of the disease-Lewy Body Syndrome Demenia, it took research and experimentation by me and the MD to realize that it was the med adn not the disease in this case. The pt has been taken off the drug and no longer has these pronounced s/s.

Zyprexa review by 43 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Bipolar Disorder Type II
Dosage & duration:		15mg taken 3 times per day for the period of approximately 2 years
Other conditions:		none
Other drugs taken:		Effexor XR & Tegretol (Carbamazapine)
		Reported Results
Benefits:		While taking Zyprexa, I never experienced any episodes of hypomania (low mania) which typically accompany Bipolar Type II; however, I attribute this mostly to the fact that Zyprexa is very sedating. It should be noted that although Zyprexa is classified as an A-typical antipsychotic, it is also used as a mood stabilizer in patients with Bipolar Disorder.
Side effects:		Increased appetite which of course lead to weight gain which caused me to feel depressed! I am not exaggerating when I say my appetite was almost insatiable. Excessive sleepiness during the day which caused me to actually start falling asleep while talking to someone on several occassions. It also made me feel almost "numb" emotionally. Sedation along with an insatiable appetite caused me to gain over 25 pounds.
Comments:		My psychiatrist prescribed Zyprexa to help with the mood swings of Bipolar Disorder. I am classified as Bipolar Type II because I do not experience the extreme highs of mania (manic episodes) that accompany Bipolar Type I. I do, however, experience hypomania (hypo meaning low) so my moods still swing from highs to the extreme lows of depression.