Mood DisordersNCT06874075
Psychiatric Disorders in Child and Adolescent Offspring of Parents with Schizophrenia and Bipolar Disorders.
An observational study of Mood Disorders and Schizophrenia Disorders, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Mood Disorders, Schizophrenia Disorders
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2025to 20 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: families with one or two parents with psychiatric disorder.
Who may be able to join
- 6_18 years IQ > 70 parents of schizophrenia \& mood disorders .
Who cannot join
- age <6 or >18 IQ < 70 .
About this study
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
Read the 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]
- Conditions
- Mood Disorders, Schizophrenia Disorders
- Keywords
- bipolar, schizophrenia
- Medical subject headings
- Mood Disorders, Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Early recognition of psychiatric disorders among children and adolescents , So Early interventions to decrease the severity of the disorder can be done
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].
Measured: 6 months
Secondary outcomes (1)
overlap of symptoms in the initial phases suggests that early identification
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start20 May 2025 (estimated)
- Primary completion20 May 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshimaa Mohamed Saad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874075
- Sponsor's protocol ID
- psychiatric marriage outcome
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Disorders in Child and Adolescent Offspring of Parents with Schizophrenia and Bipolar Disorders.
- ClinicalTrials.gov ID
- NCT06874075
- Acronym / sponsor ID
- psychiatric marriage outcome
- Conditions
- Mood Disorders, Schizophrenia Disorders
- Keywords
- bipolar, schizophrenia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- families with one or two parents with psychiatric disorder.
Key inclusion criteria (1 listed)
- 6_18 years IQ > 70 parents of schizophrenia \& mood disorders .
Key exclusion criteria (1 listed)
- age <6 or >18 IQ < 70 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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].
1 secondary outcome
overlap of symptoms in the initial phases suggests that early identification
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorders and Schizophrenia Disorders, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.