Bipolar DisorderNCT01383915
Clinical Risk State for Bipolar Disorder in Adolescents
An observational study of Bipolar Disorder and Schizophrenia, run by Northwell Health at 1 site in United States.
Trial summary
Aim: The purpose of the study is to characterize the at-risk phases preceding a first episode of bipolar disorder and of schizophrenia, and to identify clinical and biological predictors of the disease development. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Schizophrenia
- How many people
- 402 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Inpatients consecutively admitted to the adolescent inpatient unit of the Zucker Hillside Hospital, NY
Who may be able to join
- Age: 12-18 years;
- Sex: male or female;
- Race/ethnicity: no restrictions;
- Definite or suspected chart diagnosis of BP-II, BP-NOS, cyclothymia, MDD, depressive disorder NOS, dysthymia or mood disorder NOS, schizophrenifiorm disorder or psychotic disorder NOS;
- Subject and parent (if subject<18) willing and able to provide written, informed consent/assent.
Who cannot join
- Estimated Premorbid IQ < 70;
- Meets DSM-IV criteria for BP-I or schizophrenia, pervasive developmental disorder, autism spectrum disorders, current substance dependence;
- History of medical condition known to affect the brain;
- current group home affiliation.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Zucker Hillside Hospital, NSLIJ
Glen Oaks, New York, 11004
About this study
Official title: Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents
Aim: The purpose of the study is to characterize the at-risk phases preceding a first episode of bipolar disorder and of schizophrenia, and to identify clinical and biological predictors of the disease development.
Hypothesis a: Over 6-24 months, 25% of at-risk youth will develop the full manifestations of Bipolar Disorder (BPD) or schizophrenia.
Hypothesis b: The symptoms utilized for characterizing the at-risk phase of BPD will differentiate between individuals developing BPD and schizophrenia.
Read the detailed description
Prospective, naturalistic, cohort study aiming to characterizing the bipolar and psychotic prodrome thoroughly with a variety of clinical and biological measures.
- Conditions
- Bipolar Disorder, Schizophrenia
- Medical subject headings
- Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| inpatients | Youth with a clinical diagnosis of a mood disorder or psychosis spectrum disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with development of a bipolar or schizophrenia disorder
Diagnostic conversion
Measured: within 60 months
Secondary outcomes (1)
Psychopathology
Psychopathology
Measured: within 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startSep 2009
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph U. Correll, MD, Northwell Health
- Investigators
- Christoph Correll, MD, Principal investigator, The Zucker Hillside Hospital, Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383915
- Sponsor's protocol ID
- 06-123
- Status last verified
- Mar 2023
- First submitted
- 27 Jun 2011
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Gerstenberg M, Hauser M, Al-Jadiri A, Sheridan EM, Kishimoto T, Borenstein Y, Vernal DL, David L, Saito E, Landers SE, Carella M, Singh S, Carbon M, Jimenez-Fernandez S, Birnbaum ML, Auther A, Carrion RE, Cornblatt BA, Kane JM, Walitza S, Correll CU. Frequency and correlates of DSM-5 attenuated psychosis syndrome in a sample of adolescent inpatients with nonpsychotic psychiatric disorders. J Clin Psychiatry. 2015 Nov;76(11):e1449-58. doi: 10.4088/JCP.14m09435.
PubMed 26646040
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Clinical Risk State for Bipolar Disorder in Adolescents
- ClinicalTrials.gov ID
- NCT01383915
- Acronym / sponsor ID
- 06-123
- Conditions
- Bipolar Disorder, Schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Jun 2011 (estimated)
- 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.
Aim: The purpose of the study is to characterize the at-risk phases preceding a first episode of bipolar disorder and of schizophrenia, and to identify clinical and biological predictors of the disease development.
Hypothesis a: Over 6-24 months, 25% of at-risk youth will develop the full manifestations of Bipolar Disorder (BPD) or schizophrenia.
Hypothesis b: The symptoms utilized for characterizing the at-risk phase of BPD will differentiate between individuals developing BPD and schizophrenia.
Detailed description
Prospective, naturalistic, cohort study aiming to characterizing the bipolar and psychotic prodrome thoroughly with a variety of clinical and biological measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inpatients | – | –Youth with a clinical diagnosis of a mood disorder or psychosis spectrum disorder |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Inpatients consecutively admitted to the adolescent inpatient unit of the Zucker Hillside Hospital, NY
Key inclusion criteria (5 listed)
- Age: 12-18 years;
- Sex: male or female;
- Race/ethnicity: no restrictions;
- Definite or suspected chart diagnosis of BP-II, BP-NOS, cyclothymia, MDD, depressive disorder NOS, dysthymia or mood disorder NOS, schizophrenifiorm disorder or psychotic disorder NOS;
- Subject and parent (if subject<18) willing and able to provide written, informed consent/assent.
Key exclusion criteria (4 listed)
- Estimated Premorbid IQ < 70;
- Meets DSM-IV criteria for BP-I or schizophrenia, pervasive developmental disorder, autism spectrum disorders, current substance dependence;
- History of medical condition known to affect the brain;
- current group home affiliation.
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
Number of subjects with development of a bipolar or schizophrenia disorder
Time frame: within 60 months
Diagnostic conversion
1 secondary outcome
Psychopathology
Time frame: within 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 26646040Gerstenberg M, Hauser M, Al-Jadiri A, Sheridan EM, Kishimoto T, Borenstein Y, Vernal DL, David L, Saito E, Landers SE, Carella M, Singh S, Carbon M, Jimenez-Fernandez S, Birnbaum ML, Auther A, Carrion RE, Cornblatt BA, Kane JM, Walitza S, Correll CU. Frequency and correlates of DSM-5 attenuated psychosis syndrome in a sample of adolescent inpatients with nonpsychotic psychiatric disorders. J Clin Psychiatry. 2015 Nov;76(11):e1449-58. doi: 10.4088/JCP.14m09435.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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. This study is not recruiting at the moment.
Christoph Correll, MD principal investigator
The Zucker Hillside Hospital, Feinstein Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder and Schizophrenia, run by Northwell Health at 1 site in United States.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Number of subjects with development of a bipolar or schizophrenia disorder (time frame: within 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01383915, which also lists 1 linked publication.
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 4 Apr 2023.