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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 October 2021 |
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Main ID: |
NCT02037581 |
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Date of registration:
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14/01/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Integrated Care Including Assertive Community Treatment in Early Psychosis
ICEP |
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Scientific title:
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Integrated Care in Early Psychosis (ICEP Study): a 12-month Quasi Experimental Study With Historic Control Group |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02037581 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Martin Lambert, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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UHH Hamburg-Eppendorf |
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Name:
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Anne Karow, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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UHH Hamburg-Eppendorf |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
male/female, age 12-29, adequate knowledge of German language
1. Early psychosis critria according to Lewis, Tarrier, & Haddock, 2002 fullfilled: first
or second hospitalisation for psychosis during the past 2 years, duration of illness
(psychosis)=2 years
2. Diagnosis chriteria according to DSM-IV TR fullfilled for schizophrenia(295.xx
including all subtypes), schizophreniform psychosis(295.40), schizoaffektive
disorder(295.70), delusional disorder (297.1), brief psychotic episode 298.8),
psychotic disorder (298.9), bipolar I disorder (including 296.44, 296.54 and 296.64)
and major depression with psychotic symptoms (296.24 and 296.34).
Exclusion Criteria:
One of the following diagnoses according to DSM-IV TR:
Alkcohol- or substance induced psychosis (z.B. 291.3, 291.5, 292.xx: -.11 or -.12);
Psychosis according to somatic disorder(z.B. 293.0, 290.12, 290.20, 290.42, 293.89);
pregnancy.
Age minimum:
12 Years
Age maximum:
29 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Bipolar Disorder
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Intervention(s)
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Behavioral: Standard Care
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Behavioral: Early detection and Integrated Care
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Primary Outcome(s)
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Remission of psychosocial functioning
[Time Frame: 12 months]
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Secondary ID(s)
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01KQ1002B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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