NCT00919620

Brief Summary

One of the commonly adopted strategies in improving outcome in psychotic disorders is by focused, specific and intensive intervention in the initial few years of the disorder. However the effects of intervention and the optimal duration of intervention have seldom been examined in randomized studies. This study uses a randomized controlled study design to investigate the effectiveness of stage-specific case-management in improving outcome of first episode psychotic disorders. It also addresses whether two years of case-management is less effective than four years of case-management over a four year period. A total of 360 subjects, who aged 25 above, and diagnosed with first episode psychotic disorders, will be and randomized into 3 groups: (1) standard care alone without case management, (2) two-year case management, (3) four-year case management. All groups will receive usual standard care treatment. This four-year follow-up study will assess symptoms, functioning, quality of life as well as health economics data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

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

June 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

6.5 years

First QC Date

June 10, 2009

Last Update Submit

November 10, 2020

Conditions

Psychotic Disorders

Keywords

Psychotic disordersPsychoses

Outcome Measures

Primary Outcomes (1)

  • Functioning (social and occupational)

    baseline, 6-month, 12-month, 24-month, 36-month, 48-month

Secondary Outcomes (6)

  • Psychotic symptoms

    baseline, 6-month, 12-month, 24-month, 36-month, 48-month

  • Psychotic symptoms

    baseline, 6-month, 12-month, 24-month, 36-month, 48-month

  • Psychotic symptoms

    baseline, 6-month, 12-month, 24-month, 36-month, 48-month

  • Depressive symptoms

    baseline, 12-month, 24-month, 36-month, 48-month

  • Neurocognitive functioning

    baseline, 12-month, 24-month, 36-month, 48-month

  • +1 more secondary outcomes

Study Arms (3)

case management (4 yrs)

EXPERIMENTAL

4-year case management and standard care

Behavioral: stage-specific case-management

case management (2 yrs) and standard care (2 yrs)

ACTIVE COMPARATOR

2-year case management and standard care

Behavioral: stage-specific case-management

standard care (4 yrs)

NO INTERVENTION

standard care for 4 years

Interventions

stage-specific case-managementBEHAVIORAL

Stage-specific case-management for psychosis by designated key-workers according to specified protocol

case management (2 yrs) and standard care (2 yrs)case management (4 yrs)

Eligibility Criteria

Age26 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform psychosis, brief psychosis, psychosis nos or delusional disorder
  • Cantonese-speaking Chinese
  • Ability to understand the nature of the study and sign informed consent
  • Capacity to participate in cognitive testing

You may not qualify if:

  • Organic Brain disorder
  • Known history of intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

Related Publications (2)

  • Hui CLM, Wong AKH, Ho ECN, Lam BST, Hui PWM, Tao TJ, Chang WC, Chan SKW, Lee EHM, Suen YN, Lam MML, Chiu CPY, Li FWS, Leung KF, McGhee SM, Law CW, Chung DWS, Yeung WS, Yiu MGC, Pang EPF, Tso S, Lui SSY, Hung SF, Lee WK, Yip KC, Kwan KL, Ng RMK, Sham PC, Honer WG, Chen EYH. Effectiveness and optimal duration of early intervention treatment in adult-onset psychosis: a randomized clinical trial. Psychol Med. 2023 Apr;53(6):2339-2351. doi: 10.1017/S0033291721004189. Epub 2022 Feb 11.

    PMID: 35144700DERIVED

  • Puntis S, Minichino A, De Crescenzo F, Cipriani A, Lennox B, Harrison R. Specialised early intervention teams for recent-onset psychosis. Cochrane Database Syst Rev. 2020 Nov 2;11(11):CD013288. doi: 10.1002/14651858.CD013288.pub2.

    PMID: 33135811DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Eric YH Chen, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head of Department of Psychiatry

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 12, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

CN(1)