CLINICAL TRIAL

Clozapine for Schizophrenia

Recruiting · 18+ · All Sexes · Toronto, Canada

This study is evaluating whether switching to once-daily dosing of clozapine is a viable option for patients with schizophrenia.

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About the trial for Schizophrenia

Eligible Conditions
Psychotic Disorders · Schizophrenia · Schizoaffective Disorders

Treatment Groups

This trial involves 2 different treatments. Clozapine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Clozapine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clozapine
FDA approved

Side Effect Profile for Olanzapine Group

Olanzapine Group
Show all side effects
Hypersalivation
31%
Increased appetite
31%
tachycardia >100 beats/min (supine)
17%
Somnolence
15%
Constipation
15%
Hypertension
9%
Insomnia
8%
Abnormal white blood count
8%
Difficulty concentrating
8%
Enuresis
8%
Tachycardia >120 beats/min (supine)
0%
This histogram enumerates side effects from a completed 2008 Phase 4 trial (NCT00001656) in the Olanzapine Group ARM group. Side effects include: Hypersalivation with 31%, Increased appetite with 31%, tachycardia >100 beats/min (supine) with 17%, Somnolence with 15%, Constipation with 15%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Outpatient status
You must be at least 18 years old to buy cigarettes. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 0 and 12 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 0 and 12 weeks.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Clozapine will improve 1 primary outcome and 7 secondary outcomes in patients with Schizophrenia. Measurement will happen over the course of 0 and 12 weeks.

Change in the Personal and Social Performance scale (PSP) scores from baseline to 12 weeks
0 AND 12 WEEKS
Change in the Brief Psychiatric Rating Scale (BPRS) total scores from baseline to 12 weeks
0 AND 12 WEEKS
Change in the Clinical Global Impression - Severity of Illness (CGI-S) scores from baseline and 12 weeks
0 AND 12 WEEKS
Change in the Glasgow Antipsychotic Side-effect Scale for Clozapine (GASS-C) total scores from baseline to 12 weeks
0 AND 12 WEEKS
Change in the Brief Neurocognitive Assessment (BNA) Z scores from baseline to 12 weeks
0 AND 12 WEEKS
Change in the Subjective Well-being under Neuroleptics scale - Short form (SWNS) total scores from baseline to 12 weeks
0 AND 12 WEEKS
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Who is running the study

Principal Investigator
G. R.
Prof. Gary Remington, Professor
Centre for Addiction and Mental Health

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can schizophrenia be cured?

In short there is no one cure or cure for all schizophrenics, however we can make a lot of improvements in what we now do to patients and make an improvement in their lives.

Anonymous Patient Answer

What causes schizophrenia?

There are many different risk factors that explain the link between schizophrenia and bipolar disorder, and it can also be found linked to a family history. A possible contributing factor to schizophrenia is malnutrition, which is related to malnutrition as a risk factor. However, it can also be linked to certain parasites and viruses, as well. In the US, the risk of an individual diagnosed with schizophrenia is approximately 1.42 times higher than it is in the general population.

Anonymous Patient Answer

How many people get schizophrenia a year in the United States?

The incidence and prevalence rates of schizophrenia in the United States differ in different regions of the country. While the rate of incidence remains relatively stable, the prevalence of schizophrenia in the United States has increased steadily, particularly between 1991 and 2006. There appears to be a difference in the incidence and prevalence of schizophrenia across Hispanic and non-Hispanic racial/ethnic groups, and a greater prevalence of milder disease in the United States, especially among African American men.

Anonymous Patient Answer

What are the signs of schizophrenia?

A variety of signs and symptoms are encountered from the presentation of schizophrenia. Although the signs vary from one individual to another, some of these signs may be useful in facilitating clinical diagnosis.

Anonymous Patient Answer

What are common treatments for schizophrenia?

There is little evidence that one type of treatment has an advantage over another. One option for managing chronic schizophrenia is an antipsychotic drug which is often effective and relatively tolerated. A range of additional options and approaches are available.

Anonymous Patient Answer

What is schizophrenia?

Data from a recent study of this study suggest that schizophrenia is a spectrum of psychotic disorders that manifest through the occurrence of symptoms in the form of hallucinations, delusions, disorganized or catatonic symptoms. In addition, these symptoms cause distress for other close relatives. The burden of the disease, or the cost to the individual, to society, and to the individual is extremely high. It may therefore be difficult to detect the disease early.

Anonymous Patient Answer

How does clozapine work?

Clozapine is a very potent inhibitor of CYP2D6 activity and this explains its high rate of side-effects following acute dosing. There appears to be no evidence to suggest CYP2D6 plays a significant role in the metabolism of clozapine in subjects who may be co-medicated with a CYP2D6 inhibitor such as fluoxetine.

Anonymous Patient Answer

Is clozapine safe for people?

CLZ appears to be well tolerated for people with ICD. In general, patients treated with CLZ are less likely to experience side effects compared to those who are not receiving CLZ. This contrasts with preapproval studies where there was little difference between the tolerability of those being treated with CLZ, and those being treated with other antipsychotics.

Anonymous Patient Answer

What are the latest developments in clozapine for therapeutic use?

The FDA’s approval of the generic version of divalproex sodium, marketed as the generic name Clozaril, signifies that divalproex now is available as a generic and is available to the general public and not only to those in the medical community who are willing to pay for the drug. The development of the generic divalproex sulfate is less new than the new development of clozapine itself, which has been approved by the FDA and is available for the treatment of schizophrenia by prescription in combination with a low dose of an antipsychotic agent.

Anonymous Patient Answer

What are the common side effects of clozapine?

Patients taking clozapine will experience common side effects. However, these are not necessarily dangerous. In fact, if clozapine is used for a long period of time, the most prevalent side effects are less common and do not require urgent attention.

Anonymous Patient Answer

How serious can schizophrenia be?

The severity of the course of psychotic disorders can be rated. We developed criteria based on previous research and validated them in a large sample of patients. Although they were defined for clinical assessment in the outpatient setting, there is a high agreement between their ratings by the patients and by independent observers. Thus, we believe our criteria will allow assessment of the severity of schizophrenic disorders both in the outpatient and inpatient settings.

Anonymous Patient Answer

Who should consider clinical trials for schizophrenia?

The use of randomised placebo control trials to test a potential disease-modifying treatment is now accepted in medicine as the standard for assessing the efficacy of drugs for use in clinical practice. Randomised, placebo-controlled, double-blind trials are now required prior to any drugs being approved for use, even if there is some suggestion of benefit from other types of study. Given recent developments, this recommendation may come to be seen as an unjustified delay in the approval of an important treatment for patients with schizophrenia.

Anonymous Patient Answer
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