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Atypical Antipsychotic

Olanzapine + Melatonin for Schizophrenia

VA Puget Sound Health Care System, Tacoma, WA
Targeting 6 different conditionsolanzapine and melatoninN/AWaitlist AvailableLed by Amanda E Wood, PhDResearch Sponsored by Seattle Institute for Biomedical and Clinical Research

Study Summary

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

Eligible Conditions
  • Metabolic Syndrome
  • Bipolar Disorder
  • Schizoaffective Disorder
  • Obesity
  • Schizophrenia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
The doctor thinks that switching to olanzapine might help you.


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
Hip measurement
Metabolic test
+2 more

Awards & Highlights

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
52 Previous Clinical Trials
13,380 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,563 Previous Clinical Trials
3,180,642 Total Patients Enrolled
3 Trials studying Metabolic Syndrome
127 Patients Enrolled for Metabolic Syndrome
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
Metabolic Syndrome Research Study Groups: IIB (3.0 mg/day melatonin), IIA (0.3mg day melatonin)
Metabolic Syndrome 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 depressiond 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