NCT00328952

Brief Summary

The purpose of this study is to evaluate the changes in various aspects of auditory verbal hallucinations during 24-week antipsychotic treatment in naturalistic condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 16, 2009

Status Verified

September 1, 2009

Enrollment Period

4 years

First QC Date

May 22, 2006

Last Update Submit

September 15, 2009

Conditions

SchizophreniaHallucinations

Keywords

schizophreniaauditory verbal hallucinationantipsychotic treatment

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

voice-hearing patients with schizophrenia

You may qualify if:

  • Male or female patients, 15-65 years of age
  • Patients must have a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)\>
  • Patients experiencing vivid AVH confirmed by score of 4 or above using hallucinatory behavior item on Positive And Negative Syndrome Scale (PANSS).
  • Patients who are drug-naive or drug-free for more than 4 weeks.
  • Patients who are scheduled to receive atypical antipsychotic medication.
  • Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.
  • Subjects who are fluent in Korean.

You may not qualify if:

  • DSM-IV substance (except nicotine or caffeine) dependence within the past 1 year.
  • Mental retardation (IQ \< 70).
  • Neurological disorders including epilepsy, stroke, or severe head trauma.
  • Clinically significant laboratory abnormalities, on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, urinalysis and EKG.
  • Treatment with an injectable depot neuroleptic within less than three dosing interval between the last depot neuroleptic injections and baseline.
  • History of electroconvulsive therapy or transcranial magnetic stimulation within the past 3 months.
  • Subjects who are not fluent in Korean.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (4)

  • Shergill SS, Murray RM, McGuire PK. Auditory hallucinations: a review of psychological treatments. Schizophr Res. 1998 Aug 17;32(3):137-50. doi: 10.1016/s0920-9964(98)00052-8.

    PMID: 9720119BACKGROUND

  • Farhall J, Gehrke M. Coping with hallucinations: exploring stress and coping framework. Br J Clin Psychol. 1997 May;36(2):259-61. doi: 10.1111/j.2044-8260.1997.tb01411.x.

    PMID: 9167865BACKGROUND

  • Haddock G, McCarron J, Tarrier N, Faragher EB. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med. 1999 Jul;29(4):879-89. doi: 10.1017/s0033291799008661.

    PMID: 10473315BACKGROUND

  • Nayani TH, David AS. The auditory hallucination: a phenomenological survey. Psychol Med. 1996 Jan;26(1):177-89. doi: 10.1017/s003329170003381x.

    PMID: 8643757BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

routine lab tests for changes in medical condition

MeSH Terms

Conditions

SchizophreniaHallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jong-Hoon Kim, MD, PhD

    Gachon University Gil Medical Center

    STUDY DIRECTOR

  • Jung Seo Yi, MD, PhD

    Hallym University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 22, 2006

First Posted

May 24, 2006

Study Start

August 1, 2004

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

September 16, 2009

Record last verified: 2009-09

Locations

KR(1)