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Atypical Antipsychotic

Olanzapine for Schizophrenia

N/A
Waitlist Available
Led By Amanda E Wood, PhD
Research Sponsored by Seattle Institute for Biomedical and Clinical Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
Age 18-65
Must not have
Females who are pregnant or lactating
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 weeks
Awards & highlights

Summary

This trial will look at whether olanzapine, an atypical antipsychotic medication, affects melatonin levels in patients with schizophrenia, schizoaffective, or bipolar disorder.

Who is the study for?
This trial is for adults aged 18-65 with schizophrenia, schizoaffective, or bipolar disorder who may benefit from olanzapine. Women must not be pregnant and should use contraception. Exclusions include recent substance abuse, prior olanzapine use within three months, certain medication use, significant head trauma history, allergy to olanzapine, or any serious health condition.
What is being tested?
The study tests how the antipsychotic drug olanzapine affects melatonin levels in patients and whether taking melatonin can counteract changes caused by olanzapine. It's a pilot project focusing on individuals with specific mental health disorders.
What are the potential side effects?
Olanzapine can cause weight gain, increased abdominal fat, high blood sugar levels (which could lead to diabetes), and elevated cholesterol levels. Melatonin's side effects are generally mild but can include drowsiness and morning grogginess.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder.
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Nocturnal melatonin production as estimated by assay of urinary 6-sulfatoxymelatonin (aMT6s) adjusted for creatinine
Secondary study objectives
Height
Hip measurement
Metabolic test
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: IIB (3.0 mg/day melatonin)Experimental Treatment1 Intervention
3.0 mg/day melatonin
Group II: IIA (0.3mg day melatonin)Experimental Treatment1 Intervention
0.3mg day melatonin

Find a Location

Who is running the clinical trial?

Seattle Institute for Biomedical and Clinical ResearchLead Sponsor
53 Previous Clinical Trials
13,641 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,651 Previous Clinical Trials
3,224,447 Total Patients Enrolled
Amanda E Wood, PhDPrincipal InvestigatorVA Puget Sound Health Care System; University of Washington
1 Previous Clinical Trials
134 Total Patients Enrolled

Media Library

Olanzapine (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT00512070 — N/A
Olanzapine (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00512070 — N/A
Schizoaffective Disorder Research Study Groups: IIB (3.0 mg/day melatonin), IIA (0.3mg day melatonin)
Schizoaffective Disorder Clinical Trial 2023: Olanzapine Highlights & Side Effects. Trial Name: NCT00512070 — N/A
~1 spots leftby Dec 2025