Prodromal SchizophreniaNCT00169988
Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms
A study testing risperidone and sertraline-primary in people with Prodromal Schizophrenia and Psychotic Disorders, run by Northwell Health at 1 site in United States.
Trial summary
The Recognition and Prevention (RAP) Program is conducting a research study comparing an antidepressant, sertraline, alone versus in combination with a second-generation antipsychotic, risperidone, to evaluate their ability to reduce unusual thoughts, suspiciousness and other unusual experiences, to improve reasoning… Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Prodromal Schizophrenia, Psychotic Disorders
- What is being tested?
- risperidone and sertraline-primary
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Apr 2007
- Phase
- Interventional
- 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 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants are between the ages of 12 and 22.
- Participants are English-speaking.
- Participants are experiencing one or more symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences.
- Participants meet additional RAP criteria (evaluated during screening and interview).
Who cannot join
- Participants have been diagnosed with an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features.
- Participants have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain.
- Participants have a medical condition that contraindicates treatment with sertraline or risperidone.
- Participants have past or current substance dependence.
- Participants are currently taking and responding well to antidepressant or antipsychotic medication
Trial locations and contacts
1 site in 1 country.
United States1 site
RAP Program, Dept. of Psychiatry Research, The Zucker Hillside Hospital
Glen Oaks, New York, 11004
About this study
Official title: Sertraline Alone vs. in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms
The Recognition and Prevention (RAP) Program is conducting a research study comparing an antidepressant, sertraline, alone versus in combination with a second-generation antipsychotic, risperidone, to evaluate their ability to reduce unusual thoughts, suspiciousness and other unusual experiences, to improve reasoning ability, memory, attention and social skills in adolescents.
Read the detailed description
Eligible patients are enrolled in a 16-week trial consisting of symptom and side effects ratings (10 visits), monthly blood and urine tests, and neuropsychological testing at the first and last visits. At the initial appointment, all patients are assigned to sertraline and are randomly assigned to an adjunctive risperidone or placebo group. The treating physician is also blind to the medication assignment, which allows both the doctor and the patient to assess side effects and symptom improvement, unbiased by expectation. All patients receive an active medication.
- Conditions
- Prodromal Schizophrenia, Psychotic Disorders
- Being tested
- risperidone, sertraline-primary
- Keywords
- clinical high risk, attenuated positive symptoms, attenuated negative symptoms, cognition, functional status, prodromal psychosis
- Medical subject headings
- Schizotypal Personality Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
sertraline-primaryDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on attenuated positive symptom scale at 16 weeks
Score on attenuated negative symptom scale at 16 weeks
Secondary outcomes (3)
Score on social functioning measure at 16 weeks
Score on academic functioning measure at 16 weeks
Score on cognitive measures at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prodromal SchizophreniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute, Janssen Pharmaceutica N.V., Belgium, Pfizer
- Investigators
- Barbara A Cornblatt, PhD, Principal investigator, Long Island Jewish Medical Center (LIJMC)Christoph U Correll, MD, Study director, LIJMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169988
- Sponsor's protocol ID
- 05-04-103
- Status last verified
- Oct 2007
- First submitted
- 9 Sep 2005
- Last updated
- 17 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sertraline Alone vs. in Combination With Risperidone in the Treatment of Attenuated Positive and Negative Symptoms
- ClinicalTrials.gov ID
- NCT00169988
- Acronym / sponsor ID
- 05-04-103
- Conditions
- Prodromal Schizophrenia, Psychotic Disorders
- Keywords
- clinical high risk, attenuated positive symptoms, attenuated negative symptoms, cognition, functional status, prodromal psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute, Janssen Pharmaceutica N.V., Belgium, Pfizer
- Study start
- Mar 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Sep 2005 (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 Recognition and Prevention (RAP) Program is conducting a research study comparing an antidepressant, sertraline, alone versus in combination with a second-generation antipsychotic, risperidone, to evaluate their ability to reduce unusual thoughts, suspiciousness and other unusual experiences, to improve reasoning ability, memory, attention and social skills in adolescents.
Detailed description
Eligible patients are enrolled in a 16-week trial consisting of symptom and side effects ratings (10 visits), monthly blood and urine tests, and neuropsychological testing at the first and last visits. At the initial appointment, all patients are assigned to sertraline and are randomly assigned to an adjunctive risperidone or placebo group. The treating physician is also blind to the medication assignment, which allows both the doctor and the patient to assess side effects and symptom improvement, unbiased by expectation. All patients receive an active medication.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Participants are between the ages of 12 and 22.
- Participants are English-speaking.
- Participants are experiencing one or more symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences.
- Participants meet additional RAP criteria (evaluated during screening and interview).
Key exclusion criteria (5 listed)
- Participants have been diagnosed with an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features.
- Participants have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain.
- Participants have a medical condition that contraindicates treatment with sertraline or risperidone.
- Participants have past or current substance dependence.
- Participants are currently taking and responding well to antidepressant or antipsychotic medication
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 |
|---|---|---|
| risperidone | Drug | – |
| sertraline-primary | Drug | – |
Primary outcome
Score on attenuated positive symptom scale at 16 weeks
Score on attenuated negative symptom scale at 16 weeks
3 secondary outcomes
Score on social functioning measure at 16 weeks
Score on academic functioning measure at 16 weeks
Score on cognitive measures at 16 weeks
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 17 Dec 2009.
Related trials for Prodromal Schizophrenia
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)
Enrolling by invitationObservational study
Evaluation of Step-Based Care for Individuals at Clinical High Risk for Psychosis
Prodromal Schizophrenia
Not yet recruiting
Online Intervention To Improve Motivation
Schizophrenia Prodromal, SCHIZOPHRENIA 1 (Disorder)
Recruiting
Accelerated Neuromodulation Therapy and Neurocomputational Biomarkers in Individuals at Clinical High Risk for Psychosis
Clinical High Risk for Psychosis (CHR), Psychotic Disorders
Active, not recruiting
EPI-MINN: Targeting Cognition and Motivation - National
Psychosis, Psychosis Nos/Other
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.
Barbara A Cornblatt, PhD principal investigator
Long Island Jewish Medical Center (LIJMC)
Christoph U Correll, MD study director
LIJMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing risperidone and sertraline-primary in people with Prodromal Schizophrenia and Psychotic Disorders, 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 4 inclusion and 5 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 17 Dec 2009. 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.
What does the primary outcome measure?
Score on attenuated positive symptom scale at 16 weeks. The study lists 2 primary outcomes in all. 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 17 Dec 2009.