- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00468533
The Monitor of Serum Prolactin Level in a 3 Months Aripiprazole Trial
The Monitor of Serum Prolactin Level and Related Clinical Observations Among Individuals With Schizophrenia Spectrum Illnesses in a 3 Months Aripiprazole Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
This is an open-label clinical trial of adult inpatients or outpatients with a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder as measured by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). Eligible patients will have laboratory and clinical assessments completed. All procedures in this study are considered standard care and impose no additional risks to the patients. Participation is voluntary and recruitment will be on an "as come" basis.
Study Visits Schedule
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Day -7 Day 7 Day 14 Day 21 Day 28 Day 90 Baseline Initiation Endpoint prolonged f/u
Discussion of Design and Control
Because of the ethical concerns regarding withholding medication from seriously ill patients, this study does not employ a washout period. Though patients may have their antipsychotic drug held for up to 12 hours, this should not present any clinical problems in the majority of patients. This one day prevalence trial allows for clinical data to be collected in a timely manner.
Study Population
Most subjects recruited in this study are originated from a chronic psychiatric residential community. They are characterized by a regular medication with reliable drug compliance under a well-controlled diet in the unit. The subject of drug naïve will be denoted and analyzed separately in the later stage.
Entry Procedures
The patient and/or the patient's authorized legal representative prior to the patient's participation in the study will sign an informed consent document approved by an ethical review board, or similar body.
Inclusion Criteria
Patients may be included in the study if they meet the following criteria:
- Males and females 16-65 years of age
- Diagnosis of schizophrenia, schizoaffective or schizophreniform disorder
- Each individual must have a level of understanding sufficient to perform all tests and examinations required
- Individuals must be willing to fast after midnight the evening prior to study visit
- Individuals must be willing to provide a small sample of blood for evaluation
- Individuals must be willing to participate in a short 30-45 minute clinical interview
Exclusion criteria
Patients may be excluded from the study for any of the following reasons:
- A current diagnosis of diabetes mellitus
- Serious unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the condition is anticipated within 6 months
- Uncorrected hypothyroidism or hyperthyroidism
- Uncorrected tumor secreting ectopic prolactinemia
Dosage and Administration The dosage of aripiprazole will be co-administrated since day 1 with the fixed dosage of 10 mg aripiprazole per day for 1 week with the full dosage of previously used antipsychotics. The previous antipsychotics will be removed on day 8, and each individual will be assigned to either 10-15 mg aripiprazole per day (A arm) or 20-30 mg aripiprazole per day (B arm) or 10mg aripriprazole plus 1mg haldol per day (C arm) via the randomized procedure.
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 Day -7 Day 7 Day 14 Day 21 Day 28 Day 60 Day 90 Previous antispychotics Full dosage stop - - - A arm (N=16) 10mg 10-15mg 10-15mg 10-15mg 10-15mg 10-15mg B arm (N=16) 10mg 20-30 mg 20-30 mg 20-30 mg 20-30 mg 20-30 mg C arm (N=16) 10mg 10mg (+ 1-2 mg haldol) 10mg (+ 1-2 mg haldol) 10mg (+ 1-2 mg haldol) 10mg (+ 1-2 mg haldol) 10mg (+ 1-2 mg haldol) Denotation: C arm is designed for the purpose of evaluation on add-on effect from typical antipsychotics with a high potency such as haldol. The difference between C arm and the other two might be minimal or significant due to different reaction in Asian population or Chinese population.
In addition to the necessary prescription of antipsychotics described as above listed, adequate amount of benzodiazepines and anticholinergics are permitted to give to alleviate the possible anxiety, insomnia, and EPS as an adjunctive agent simultaneously.
Table 1
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 Day -7 Day 7 Day 14 Day 21 Day 28 Day 60 Day 90 CGI x x x x x x x DRA x x x x PANSS x x x x AIMS x x x x SAS x x x x SWN x x x x Demographic Sheet x
Clinical Laboratory Tests Clinical laboratory testing will be performed at Visit 1, 2, 3, 4, 5, 6. See Table2 for a complete list of tests to be performed. Patients will be asked to fast after midnight (at least 8 hours) prior to labwork. If a patient is to take morning medications, he/she is asked to hold the morning medications until after the labwork is drawn. He or she may take the medication immediately after the labs have been drawn. Note: A patient is permitted to go off site to have his/her labs drawn. Labwork must be drawn within 3 days of time the demographic and other data is/was gathered.
Table 2
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 Day -7 Day 7 Day 14 Day 21 Day 28 Day 60 Day 90 Prolactin x x x x x x x Leptin x x x x Estrogen x x x x Glusoce x x x x x x x Insulin x x x x x x x Total cholesterol x x x x HDL x x x x LDL x x x x Triglycerides x x x x
Other Clinical Assessments Hypertension is defined as systolic blood pressure (SBP) of 140 mm Hg or greater, diastolic blood pressure (DBP) of 90 mm Hg or greater, or taking antihypertension medication. Obesity is defined as a Body Mass Index (BMI) of 30 or greater.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Tsuo-Hung Lan, MD, PhD
- Phone Number: 2221 886-3-8886141
- Email: tosafish@gmail.com
Study Locations
-
-
-
Hualien, Taiwan, 981
- Recruiting
- Yu-Li Hospital, DOH
-
Contact:
- Hsien-Jane Chiu, MD, MPH, PhD
- Phone Number: 2220 03-8886141
- Email: ylh.ebmc@gmail.com
-
Principal Investigator:
- Tsuo-Hung Lan, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients may be included in the study if they meet the following criteria:
- Males and females 16-65 years of age
- Diagnosis of schizophrenia, schizoaffective or schizophreniform disorder
- Each individual must have a level of understanding sufficient to perform all tests and examinations required
- Individuals must be willing to fast after midnight the evening prior to study visit
- Individuals must be willing to provide a small sample of blood for evaluation
- Individuals must be willing to participate in a short 30-45 minute clinical interview
Exclusion Criteria:
Patients may be excluded from the study for any of the following reasons:
- A current diagnosis of diabetes mellitus
- Serious unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the condition is anticipated within 6 months
- Uncorrected hypothyroidism or hyperthyroidism
- Uncorrected tumor secreting ectopic prolactinemia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
prolactin level drops after shifting to aripiprazole
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlations between prolactin and other clinical outcomes
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tsuo-Hung Lan, MD, PhD, Yu-Li Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Glucose Metabolism Disorders
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Schizophrenia Spectrum and Other Psychotic Disorders
- Movement Disorders
- Insulin Resistance
- Hyperinsulinism
- Dyskinesia, Drug-Induced
- Schizophrenia
- Metabolic Syndrome
- Dyskinesias
- Tardive Dyskinesia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- YLH-IRB-9506
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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