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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
Females must be of non-child bearing potential (i.e., surgically sterilized, or at least one year post-menopausal) or on an appropriate dose of oral/depot contraceptives or using barrier protection and not breast-feeding. Females must have a urine pregnancy test at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 not able to have children, am not pregnant, and if sexually active, I use birth control.
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I am between 18 and 65 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nocturnal melatonin production as estimated by assay of urinary 6-sulfatoxymelatonin (aMT6s) adjusted for creatinine
Secondary outcome measures
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
52 Previous Clinical Trials
13,380 Total Patients Enrolled
2 Trials studying Obesity
703 Patients Enrolled for Obesity
Eli Lilly and CompanyIndustry Sponsor
2,605 Previous Clinical Trials
3,199,650 Total Patients Enrolled
52 Trials studying Obesity
40,740 Patients Enrolled for Obesity
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
Obesity Research Study Groups: IIB (3.0 mg/day melatonin), IIA (0.3mg day melatonin)
Obesity Clinical Trial 2023: Olanzapine Highlights & Side Effects. Trial Name: NCT00512070 — N/A

Frequently Asked Questions

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

What medical conditions usually respond to treatment with olanzapine and melatonin?

"Olanzapine and melatonin have been clinically demonstrated to ameliorate acute coryza, mental depression, and post traumatic stress disorder (PTSD)."

Answered by AI

Is it feasible for me to participate in this experiment?

"The requirements to join this trial are a diagnosis of schizophrenia and an age between 18-65. At present, roughly 20 participants must be recruited."

Answered by AI

How many subjects are currently involved with this clinical research?

"The trial, which was initially announced on July 1st 2007 and last modified on October 6th 2022, is no longer seeking participants. For those searching for alternative trials, 2513 studies concerning schizophrenia are currently open to recruitment and 42 medical investigations involving olanzapine in combination with melatonin require patients."

Answered by AI

Is the group of participants for this study limited to those under 45 years old?

"This clinical trial is only for those aged between 18 and 65. Patients under 18 have access to 592 trials, while 1597 studies are available to persons over the age of 65."

Answered by AI

Are there any existing records of research regarding the combination of olanzapine and melatonin?

"Currently, there are 42 ongoing clinical trials involving olanzapine and melatonin with 8 at the later Phase 3. Of these experiments, a few take place in Toronto but 730 other medical centres across the world have active studies concerning this combination of medications."

Answered by AI

Is this an innovatory clinical experiment?

"To date, 42 active clinical trails regarding olanzapine and melatonin have been conducted across 407 cities in 13 nations. The inaugural experiment was commissioned by Eli Lilly & Company in 2007 and featured 20 patients who successfully completed the necessary trials for drug approval. Since then, 335 additional experiments have been carried out."

Answered by AI

Is this experiment presently enrolling participants?

"Unfortunately, the trial is not accepting enrolments at present. It was first posted on July 1st 2007 and most recently edited October 6th 2022. Alternatively, there are 2513 trials recruiting people with schizophrenia and 42 studies involving olanzapine and melatonin currently enrolling participants."

Answered by AI
~2 spots leftby Dec 2025