The Monitor of Serum Prolactin Level in a 3 Months Aripiprazole Trial

NCT00468533 | Unknown Phase 4 DMC

• 1 other identifier: YLH-IRB-9506
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A short term post-market monitoring of serum prolactin level change among patients with schizophrenia shifting from other antispychotics to different dosages of aripiprazole.

Conditions

Schizophrenia, Tardive Dyskinesia, Metabolic Syndrome

Keywords

Arupiprazole, prolacin, PANSS, CGI, AIMS

Outcome Measures

Primary Outcomes (1)

• prolactin level drops after shifting to aripiprazole

  3 months

Secondary Outcomes (1)

• correlations between prolactin and other clinical outcomes

  6 months

Interventions

Aripiprazole DRUG

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yu-Li Hospital: lead

Study Sites (1)

Yu-Li Hospital, DOH

Hualien City, Hualien, 981, Taiwan

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Tardive Dyskinesia; Metabolic Syndrome

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tsuo-Hung Lan, MD, PhD

  Yu-Li Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsuo-Hung Lan, MD, PhD

CONTACT

886-3-8886141; tosafish@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2007
• First Posted: May 2, 2007
• Study Start: May 1, 2006
• Study Completion: July 1, 2007
• Last Updated: May 2, 2007

Record last verified: 2007-04

Locations

TW (1)