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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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
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 belowSelect...
I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder.
Select...
I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 weeks
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 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2,667 Previous Clinical Trials
3,228,457 Total Patients Enrolled
31 Trials studying Bipolar Disorder
6,473 Patients Enrolled for Bipolar Disorder
Amanda E Wood, PhDPrincipal InvestigatorVA Puget Sound Health Care System; University of Washington
1 Previous Clinical Trials
134 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I have taken olanzapine in the last three months.I do not have any major health issues that could worsen by joining this study or affect my participation.You have been diagnosed with substance abuse or addiction in the last 30 days.Patients who the doctor thinks might need to switch to olanzapine will be excluded.I have not taken fluvoxamine, nifedipine, or warfarin in the last 30 days.You have had a serious head injury that caused you to lose consciousness for more than five minutes or have lasting problems with thinking or movement.I have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder.I am not able to have children, am not pregnant, and if sexually active, I use birth control.You have had a bad reaction or couldn't tolerate olanzapine before.I am between 18 and 65 years old.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: IIB (3.0 mg/day melatonin)
- Group 2: IIA (0.3mg day melatonin)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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