SchizophreniaPhase 4NCT04020588
Anti-inflammatories and Adolescent Schizophrenia
A Phase 4 study testing Celecoxib 200mg and Minocycline 100mg in people with Schizophrenia, run by Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico at 1 site in Mexico.
Trial summary
A double-blind controlled trial assessing the efficacy of anti-inflammatories on symptoms and cognition of adolescents with schizophrenia Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Celecoxib 200mg and Minocycline 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteMexico
- Study dates
- 25 Feb 2019to Dec 2020
- Phase
- Phase 4
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of schizophrenia or schizophreniform disorder.
- Patients in their first psychotic episode or previously diagnosed
- No specific pharmacological treatment (antipsychotic at therapeutic doses in regular doses) in the previous two weeks.
- Have a responsible parent or guardian.
Who cannot join
- Active infection
- Chronic somatic diseases, including autoimmune diseases
- Comorbidity with anorexia, substance use disorders
- Pregnancy
- Use of anti-inflammatory medications or antibiotics
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Psiquiatrico Infantil
Mexico City, Ni Ee.uu. Ni Canadá, 14080
Rosa E Ulloa, M.D., 5555739161, eulloa@hotmail.com
About this study
Official title: Effect of Anti-inflammatory Treatments on the Symptoms, Cognition, and Functioning of Adolescents With Schizophrenia
A double-blind controlled trial assessing the efficacy of anti-inflammatories on symptoms and cognition of adolescents with schizophrenia
Read the detailed description
Patients will be evaluated to confirm the diagnosis of schizophrenia, duration of the disease and record a history of atopic diseases or recurrent infections throughout life. The PANSS, PSP, and MCCB battery scales will be administered. A blood sample will be taken for the determination of markers of inflammation before the start of pharmacological treatment.
Patients will start the antipsychotic medication assigned by their treating physician. They will also be assigned randomly to the treatment arm. The study drug will be provided by the research team under the presentation of capsules containing Celecoxib 200 mg, Minocycline 100 mg or Placebo, and patients will be instructed to take one capsule every 12 hrs daily.
The patient will be reassessed with PANSS, PSP, and MCCB after completing 6 weeks of pharmacological treatment, type and dose of medication will be recorded and serum markers of inflammation will be determined again.
- Conditions
- Schizophrenia
- Being tested
- Celecoxib 200mg, Placebo oral capsule, Minocycline 100mg
- Keywords
- schizophrenia, adolescents, inflammation, anti-inflammatory
- Medical subject headings
- Schizophrenia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celecoxib 200mgDrug
Also called Minocycline 100 mg, Minocycline
Will be administered for 6 weeks
Placebo oral capsuleDrug
Also called Placebo
Will be administered for 6 weeks
Minocycline 100mgDrug
Also called Minocycline
Will be administered for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib | Active comparator | Celecoxib 200 mg twice a day Receives: Drug: Celecoxib 200mg |
| Minocycline | Active comparator | Minocycline 100 mg twice a day Receives: Drug: Minocycline 100mg |
| Placebo | Placebo comparator | Placebo capsules twice a day Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity: Positive and Negative Syndrome Scale score
Change in the Positive and Negative Syndrome Scale score, which comprises 33 items which can be scored from 1 (absent) to 7 (extreme), evaluating an array of symptoms including positive, negative, neuromotor, depressive and anxious, and involves the use of data from patient reports, caregiver reports, and clinical observations. The total score is the sum or all the items, the maximum score is 231. The higher values represent a worse outcome
Measured: six weeks
Cognition: MATRICS Consensus Cognitive Battery (MCCB) scores
Change in MCCB scores. The MCCB is comprised of 9 tests that reflect 7 dimensions of neurocognitive dysfunction in schizophrenia, including: Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, and Reasoning and Problem Solving and Social Cognition. The MCCB scoring program yields the domain scores and a composite score which are standardized to the same T-score measurement scale with a mean of 50 and an SD of 10 based upon the normative data.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start25 Feb 2019
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020588
- Sponsor's protocol ID
- II3/02/0618
- Status last verified
- Aug 2019
- First submitted
- 12 Jul 2019
- Last updated
- 3 Sep 2019
- 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 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anti-inflammatory Treatments on the Symptoms, Cognition, and Functioning of Adolescents With Schizophrenia
- ClinicalTrials.gov ID
- NCT04020588
- Acronym / sponsor ID
- II3/02/0618
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, adolescents, inflammation, anti-inflammatory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, MexicoOther government
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Jul 2019 (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.
A double-blind controlled trial assessing the efficacy of anti-inflammatories on symptoms and cognition of adolescents with schizophrenia
Detailed description
Patients will be evaluated to confirm the diagnosis of schizophrenia, duration of the disease and record a history of atopic diseases or recurrent infections throughout life. The PANSS, PSP, and MCCB battery scales will be administered. A blood sample will be taken for the determination of markers of inflammation before the start of pharmacological treatment.
Patients will start the antipsychotic medication assigned by their treating physician. They will also be assigned randomly to the treatment arm. The study drug will be provided by the research team under the presentation of capsules containing Celecoxib 200 mg, Minocycline 100 mg or Placebo, and patients will be instructed to take one capsule every 12 hrs daily.
The patient will be reassessed with PANSS, PSP, and MCCB after completing 6 weeks of pharmacological treatment, type and dose of medication will be recorded and serum markers of inflammation will be determined again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Active comparator | Drug: Celecoxib 200mgCelecoxib 200 mg twice a day |
| Minocycline | Active comparator | Drug: Minocycline 100mgMinocycline 100 mg twice a day |
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo capsules twice a day |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia or schizophreniform disorder.
- Patients in their first psychotic episode or previously diagnosed
- No specific pharmacological treatment (antipsychotic at therapeutic doses in regular doses) in the previous two weeks.
- Have a responsible parent or guardian.
Key exclusion criteria (5 listed)
- Active infection
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 |
|---|---|---|
| Celecoxib 200mgAlso: Minocycline 100 mg, MinocyclineWill be administered for 6 weeks | Drug | Celecoxib |
| Placebo oral capsuleAlso: PlaceboWill be administered for 6 weeks | Drug | Placebo |
| Minocycline 100mgAlso: MinocyclineWill be administered for 6 weeks | Drug | Minocycline |
Primary outcome
Symptom severity: Positive and Negative Syndrome Scale score
Time frame: six weeks
Change in the Positive and Negative Syndrome Scale score, which comprises 33 items which can be scored from 1 (absent) to 7 (extreme), evaluating an array of symptoms including positive, negative, neuromotor, depressive and anxious, and involves the use of data from patient reports, caregiver reports, and clinical observations. The total score is the sum or all the items, the maximum score is 231. The higher values represent a worse outcome
Cognition: MATRICS Consensus Cognitive Battery (MCCB) scores
Time frame: six weeks
Change in MCCB scores. The MCCB is comprised of 9 tests that reflect 7 dimensions of neurocognitive dysfunction in schizophrenia, including: Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, and Reasoning and Problem Solving and Social Cognition. The MCCB scoring program yields the domain scores and a composite score which are standardized to the same T-score measurement scale with a mean of 50 and an SD of 10 based upon the normative data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celecoxib 200mg and Minocycline 100mg in people with Schizophrenia, run by Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico at 1 site in Mexico.
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: status not confirmed, as of the sponsor's last update on 3 Sep 2019. 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 Mexico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Rosa Ulloa, M.D (+525555739161, eulloa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom severity: Positive and Negative Syndrome Scale score (time frame: six 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 3 Sep 2019.