Psychotic DisorderNCT01724372
The Role of Antidepressants or Antipsychotics in Preventing Psychosis
A study testing Antidepressant and Antipsychotic in people with Psychotic Disorder, run by St. Luke's-Roosevelt Hospital Center.
Trial summary
This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk for developing psychosis. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Psychotic Disorder
- What is being tested?
- Antidepressant and Antipsychotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to May 2014
- 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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12-25 years of age (inclusive)
- Able to understand and speak English
- Have at least one sub-threshold positive psychotic symptom that is moderate, moderately severe, or severe
Who cannot join
- Lifetime diagnosis of an Axis I psychotic disorder: schizophreniform disorder; schizophrenia; schizoaffective disorder; bipolar disorder; or major depression with psychotic features
- Current psychosis
- Current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features
- Lifetime diagnosis of substance abuse or dependence (excluding nicotine)
- Current stimulant treatment
- Any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine, including history of neurological, neuroendocrine or other medical condition known to affect the brain
- Estimated intelligence quotient < 70
About this study
This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk for developing psychosis.
Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated and will lead to greater improvement in symptoms at the end of 6 months of treatment.
- Conditions
- Psychotic Disorder
- Being tested
- Antidepressant, Antipsychotic
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntidepressantDrug
Also called Fluoxetine
AntipsychoticDrug
Also called Aripiprazole
| Study group | Role | What they receive |
|---|---|---|
| Antidepressant | Experimental | Fluoxetine Receives: Drug: Antidepressant |
| Antipsychotic | Active comparator | Aripiprazole Receives: Drug: Antipsychotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attenuated positive, negative and general psychiatric symptoms
To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.
Measured: 6 months
Secondary outcomes (3)
Social and role functioning
To compare the effect of fluoxetine and aripiprazole on social and role functioning and subjective well-being in individuals at risk for schizophrenia.
Measured: 6 months
Time to all-cause discontinuation.
To compare aripiprazole and fluoxetine on time to all-cause discontinuation or need to add another psychiatric medication.
Measured: 6 months
Adverse effects
To compare aripiprazole and fluoxetine on the presence of associated rates of adverse effects.
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 posted9 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Zucker Hillside Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724372
- Sponsor's protocol ID
- 12-094
- Status last verified
- Nov 2012
- First submitted
- 1 Nov 2012
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Antidepressants or Antipsychotics in Preventing Psychosis
- ClinicalTrials.gov ID
- NCT01724372
- Acronym / sponsor ID
- 12-094
- Conditions
- Psychotic Disorder
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- The Zucker Hillside Hospital
- Study start
- Oct 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 9 Nov 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.
This is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk for developing psychosis.
Our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated and will lead to greater improvement in symptoms at the end of 6 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antidepressant | Experimental | Drug: AntidepressantFluoxetine |
| Antipsychotic | Active comparator | Drug: AntipsychoticAripiprazole |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 12-25 years of age (inclusive)
- Able to understand and speak English
- Have at least one sub-threshold positive psychotic symptom that is moderate, moderately severe, or severe
Key exclusion criteria (7 listed)
- Lifetime diagnosis of an Axis I psychotic disorder: schizophreniform disorder; schizophrenia; schizoaffective disorder; bipolar disorder; or major depression with psychotic features
- Current psychosis
- Current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features
- Lifetime diagnosis of substance abuse or dependence (excluding nicotine)
- Current stimulant treatment
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 |
|---|---|---|
| AntidepressantAlso: Fluoxetine | Drug | Antidepressant |
| AntipsychoticAlso: Aripiprazole | Drug | Antipsychotic |
Primary outcome
Attenuated positive, negative and general psychiatric symptoms
Time frame: 6 months
To compare fluoxetine and aripiprazole on the likelihood of and time to symptomatic improvement.
3 secondary outcomes
Social and role functioning
Time frame: 6 months
Time to all-cause discontinuation.
Time frame: 6 months
Adverse effects
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Antidepressant and Antipsychotic in people with Psychotic Disorder, run by St. Luke's-Roosevelt Hospital Center.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 26 May 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Attenuated positive, negative and general psychiatric symptoms (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 26 May 2014.