Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000514606
Ethics application status
Approved
Date submitted
20/09/2005
Date registered
26/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
EPISODE II: Prevention of relapse following early psychosis
Scientific title
EPISODE II: Prevention of relapse following early psychosis using combined family and individual CBT
Universal Trial Number (UTN)
Trial acronym
Episode II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early psychosis 639 0
Condition category
Condition code
Mental Health 712 712 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to evaluate via a randomized controlled trial a combined individual and family-based psychosocial intervention aimed at relapse prevention following remission from first-episode psychosis in young people aged 15-25 years compared with treatment as usual in a first episode psychosis service.
Intervention code [1] 654 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 869 0
Evaluation will include the rate of relapse for participants in the relapse-prevention intervention (of approximately 6-months duration), compared with treatment as usual within a specialized first-episode service
Timepoint [1] 869 0
At 6 month intervals over a 2 year period
Primary outcome [2] 870 0
Evaluation will include the time to relapse for participants in the relapse-prevention intervention (of approximately 6-months duration), compared with treatment as usual within a specialized first-episode service
Timepoint [2] 870 0
At 6 month intervals over a 2 year period
Secondary outcome [1] 1735 0
The impact upon awareness of illness, secondary morbidity, quality of life, medication adherence, substance abuse, and family burden will be evaluated using standardized interview schedules and questionnaires.
Timepoint [1] 1735 0
At 6-monthly intervals over a 2-year period following participation in the relapse-prevention intervention (of approximately 6-months duration), compared with treatment as usual within a specialized first-episode service.

Eligibility
Key inclusion criteria
(1) Eligible for EPPIC services (DSM-IV diagnosis of a psychotic disorder or mood disorder with psychotic features, no more than 6 months of prior treatment with an antipsychotic prior to registration with EPPIC) and Barwon Heath First Episode Psychosis Service (see EPPIC criteria above), with a maximum of 12 months of treatment received within the service; (2) Able to converse in English without an interpreter; and (3) Have reached complete, or near-complete remission of positive psychotic sypmtoms for a 1-month period, determined by scores on the expanded BPRS (Overall & Gorham, 1962) of 3 or less on the items hallucinations, conceptual disorganization, suspiciousness and unusual thought content.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Unable to converse in, or read English without an interpreter; (2)Severe intellectual disability; (3)Persistent positive psychotic symptoms; and (4) Psychotic disorder due to a medical condition.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation procedure was set up in a Microsoft Access database and the sequence of randomisation was concealed until the interventions were assigned per case. Randomisation was controlled and concealed by the statistician involved in the study and was not available to any other members of the team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number computer program, password secured
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
An effectiveness study with treatment as usual as a control
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
29/10/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 788 0
Other Collaborative groups
Name [1] 788 0
Lily-Map Consortium
Country [1] 788 0
Australia
Primary sponsor type
Individual
Name
Eli Lily
Address
Country
Secondary sponsor category [1] 652 0
None
Name [1] 652 0
nil
Address [1] 652 0
Country [1] 652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2073 0
ORYGEN Youth Health and Barwon Health
Ethics committee address [1] 2073 0
Ethics committee country [1] 2073 0
Australia
Date submitted for ethics approval [1] 2073 0
Approval date [1] 2073 0
Ethics approval number [1] 2073 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35516 0
Address 35516 0
Country 35516 0
Phone 35516 0
Fax 35516 0
Email 35516 0
Contact person for public queries
Name 9843 0
John Gleeson
Address 9843 0
ORYGEN Youth Health
35 Poplar Rd
Parkville VIC 3052
Country 9843 0
Australia
Phone 9843 0
+61 409386523
Fax 9843 0
Email 9843 0
[email protected]
Contact person for scientific queries
Name 771 0
Belinda Newman
Address 771 0
ORYGEN Youth Health
35 Poplar Rd
Parkville VIC 3052
Country 771 0
Australia
Phone 771 0
+61 412848864
Fax 771 0
Email 771 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.