- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06874075
Psychiatric Disorders in Child and Adolescent Offspring of Parents with Schizophrenia and Bipolar Disorders.
Study Overview
Status
Conditions
Detailed Description
Offspring of parents with bipolar disorder (BD) and schizophrenia (SZ) are vulnerable and at high risk for these disorders. Despite the fact that positive family history of SZ or BD is the strongest predictor for the development of these severe mental illnesses, there is limited evidence assessing young adults of SZ and BP simultaneously with lack of detailed handling of similarities in risk and developmental trajectories during adolescence [1, 2]. SZ and BP are thought to share a common pathophysiological basis due to advances in the field of molecular genetics, which have yielded overlapping findings between the two disorders [3, 4]. The psychopathological base during adolescence is influenced by neurodevelopmental deviation prior to clinical onset of many severe mental illnesses [5, 6]. Moreover, the risk for developing psychopathology is high during adolescence and prodromal symptoms start even earlier and may overlap and are difficult to differentiate [5-8]. This has turned efforts towards identification and treatment of individuals at early stages of the illness, when first clinical manifestations emerge [8, 9].
Importantly, subthreshold symptoms of mania and depression along with unspecific behavioural, emotional, and cognitive manifestations are highly predictive of future manic and depressive episodes in BD as well as anxiety disorders, which is confirmed by the clinical staging perspective [10, 11]. Nevertheless, early recognition and intervention during the prodromal phase is still at an early stage in Sz [12] with limited research into valid prodromal criteria for BP [13]. Retrospective studies combining subjects with early-onset mania and early-onset first-episode psychosis have reported a similar pattern of neurodevelopmental and psychopathological features predating the appearance of more specific prodromal symptoms in both disorders [14, 15]. Therefore, the substantial overlap of symptoms in the initial phases suggests that early identification programmes should be aimed at detecting both the pre-psychotic and the pre-manic phases of SZ and BP [16]
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 6_18 years IQ > 70 parents of schizophrenia & mood disorders .
Exclusion Criteria:
- age <6 or >18 IQ < 70 .
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Early recognition of psychiatric disorders among children and adolescents , So Early interventions to decrease the severity of the disorder can be done
Time Frame: 6 months
|
Early recognition and intervention during the prodromal phase is still at an early stage in Sz [12] with limited research into valid prodromal criteria for BP [13].
Retrospective studies combining subjects with early-onset mania and early-onset first-episode psychosis have reported a similar pattern of neurodevelopmental and psychopathological features predating the appearance of more specific prodromal symptoms in both disorders [14, 15].
Therefore, the substantial overlap of symptoms in the initial phases suggests that early identification programmes should be aimed at detecting both the pre-psychotic and the pre-manic phases of SZ and BP [16].
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
overlap of symptoms in the initial phases suggests that early identification
Time Frame: 6 months
|
overlap of symptoms in the initial phases suggests that early identification programmes should be aimed at detecting both the pre-psychotic and the pre-manic phases of schizophrenia and bipolar disorders.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- psychiatric marriage outcome
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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