NCT01047215

Brief Summary

The goal of this research is investigating the heart rate changes in schizophrenic and bipolar patients under the medication of aripiprazole and quetiapine. In the mean time, we are hoping further investigating the interrelationship of medicine dosage and heart rate change, in order to acquire the best relationship both effectiveness as well as safety in acceptable heart rate change of clinical suggestion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 12, 2010

Status Verified

January 1, 2010

Enrollment Period

Same day

First QC Date

January 6, 2010

Last Update Submit

January 11, 2010

Conditions

SchizophreniaBipolar

Keywords

schizophreniabipolararipiprazolequetiapine

Study Arms (2)

Aripipazole

ACTIVE COMPARATOR

Heart rate change in schizophrenic and bipolar patients under the aripipazole and quetiapine medication

Drug: Aripiprazole; Quetiapine

Quetiapine

ACTIVE COMPARATOR

Heart rate change in schizophrenic and bipolar patients under the aripipazole and quetiapine medication

Drug: Aripiprazole; Quetiapine

Interventions

Aripiprazole; QuetiapineDRUG

Aripiprazole Quetiapine

AripipazoleQuetiapine

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 to 50, all genders.
  • Psychiatry doctor diagnosed who met DSM-IV-TR criteria schizophrenia or bipolar patients and using antipsychotics.
  • Psychiatry doctor first diagnosed who met DSM-IV-TR criteria schizophrenia or bipolar patients and without using antipsychotics.
  • Participants understand the goal of this experiment and willing to cooperate for evaluating heart rate change measurement. Participants need to understand the procedure of this study.
  • Participants voluntarily join this interview, approximately 30-45min.
  • Clinical reviewed patient's condition need to use quetiapine or aripiprazole.
  • Control group
  • Age between 20 to 50, all genders.
  • Psychiatry doctor diagnosed who exclude DSM-IV-TR schizophrenia or bipolar patients.
  • Participants understand the goal of this experiment and willing to cooperate for evaluating heart rate change measurement. Participants need to understand the procedure of this study.
  • Participants voluntarily join this interview, approximately 30-45min.

You may not qualify if:

  • Experimential Group:
  • Participants fail to understand the goal of this experiment and unwilling to cooperate for evaluating heart rate change measurement.
  • Participants have cardio-vascular disease, diabetes, hepatic cirrhosis, kidney disease, material abuser (smoking not excluded) and long-term-effective psychotics user.
  • Participant has combination diseases, it could seriously influence diagnosis.
  • Psychopathy or psychosis can not be categorized in defined group.
  • Clinical reviewed patient's condition need to switch other medicine.
  • Clinical reviewed patient's condition need to quite this experiment and record reasons.
  • Participants decide to quite experiment without any conditions.
  • Control group
  • Participants fail to understand the goal of this experiment and unwilling to cooperate for evaluating heart rate change measurement.
  • Participants have cardio-vascular disease, diabetes, hepatic cirrhosis, kidney disease, material abuser (smoking not excluded) and long-term-effective psychotics user.
  • Participants decide to quite experiment without any conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

AripiprazoleQuetiapine Fumarate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-Ring

Study Officials

  • Tsuo-Hung Lan, MD., PhD.

    Taichung Veterans General Hospital

    STUDY DIRECTOR

  • Tsuo-Hung Lan, MD.,PhD

    Taichung Veterans General Hospital

    STUDY DIRECTOR

Central Study Contacts

Tsuo-Hung Lan, MD., PhD.

CONTACT

04-23592525tosafish@hotmail.com

Jui-Hung Lin, MD.

CONTACT

0966381995ryohoki.ryoko@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 12, 2010

Study Start

August 1, 2009

Primary Completion

August 1, 2009

Study Completion

June 1, 2010

Last Updated

January 12, 2010

Record last verified: 2010-01

Locations

TW(1)