Psychotic DisordersNCT01688765
Longitudinal Multimodal Neuroimaging Studies in Patients With First Episode Psychosis
An observational study of Psychotic Disorders, run by Mclean Hospital at 1 site in United States.
Trial summary
The purpose of this study is to investigate the structural, functional and chemical brain abnormalities in patients with first episode psychosis and assess the evolution of these abnormalities during the course of the disease. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Observational
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2012to 23 Sep 2022
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: First episode psychosis patients Healthy controls
Who may be able to join
- Clinical diagnosis of first episode of a psychotic disorder
- Healthy controls with no psychiatric disorder history
Who cannot join
- Significant neurological or medical illness history
- Ages <18 or >45
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the structural, functional and chemical brain abnormalities in patients with first episode psychosis and assess the evolution of these abnormalities during the course of the disease.
Read the detailed description
The purpose of this study is to investigate the structural, functional and chemical brain abnormalities in patients with first episode psychosis and assess the evolution of these abnormalities during the course of the disease.
The study design is case-control, there are no interventions.
- Conditions
- Psychotic Disorders
- Being tested
- Observational
- Keywords
- Schizophrenia, Schizoaffective disorder, Bipolar disorder
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
| Study group | Role | What they receive |
|---|---|---|
| First Episode Psychosis Patients | Individuals experiencing a first episode of psychosis Receives: Other: Observational | |
| Healthy Controls | Psychiatrically healthy individuals Receives: Other: Observational |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study start17 Oct 2012
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dost Ongur, Mclean Hospital
- Investigators
- Dost Ongur, MD PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688765
- Sponsor's protocol ID
- 2012P001796
- Status last verified
- Sep 2022
- First submitted
- 17 Sep 2012
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Multimodal Neuroimaging Studies in Patients With First Episode Psychosis
- ClinicalTrials.gov ID
- NCT01688765
- Acronym / sponsor ID
- 2012P001796
- Conditions
- Psychotic Disorders
- Keywords
- Schizophrenia, Schizoaffective disorder, Bipolar disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 17 Oct 2012 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 20 Sep 2012 (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.
The purpose of this study is to investigate the structural, functional and chemical brain abnormalities in patients with first episode psychosis and assess the evolution of these abnormalities during the course of the disease.
Detailed description
The purpose of this study is to investigate the structural, functional and chemical brain abnormalities in patients with first episode psychosis and assess the evolution of these abnormalities during the course of the disease.
The study design is case-control, there are no interventions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Episode Psychosis Patients | – | Other: ObservationalIndividuals experiencing a first episode of psychosis |
| Healthy Controls | – | Other: ObservationalPsychiatrically healthy individuals |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- First episode psychosis patients Healthy controls
Key inclusion criteria (2 listed)
- Clinical diagnosis of first episode of a psychotic disorder
- Healthy controls with no psychiatric disorder history
Key exclusion criteria (2 listed)
- Significant neurological or medical illness history
- Ages <18 or >45
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational | Other | First Episode Psychosis Patients, Healthy Controls |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
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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. This study is not recruiting at the moment.
Dost Ongur, MD PhD principal investigator
Mclean Hospital
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 Psychotic Disorders, run by Mclean Hospital 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 27 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 27 Sep 2022.