Anti-inflammatories and Adolescent Schizophrenia

Study Overview
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Brief Summary
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A double-blind controlled trial assessing the efficacy of anti-inflammatories on symptoms and cognition of adolescents with schizophrenia

Detailed Description
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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.

Official Title
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Effect of Anti-inflammatory Treatments on the Symptoms, Cognition, and Functioning of Adolescents With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Celecoxib 200mg
* Drug: Placebo oral capsule
* Drug: Minocycline 100mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Active infection Chronic somatic diseases, including autoimmune diseases Comorbidity with anorexia, substance use disorders Pregnancy Use of anti-inflammatory medications or antibiotics

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Celecoxib<br>Celecoxib 200 mg twice a day | Drug: Celecoxib 200mg<br>* Will be administered for 6 weeks<br>* Other names: Minocycline;|
| Active Comparator: Minocycline<br>Minocycline 100 mg twice a day | Drug: Minocycline 100mg<br>* Will be administered for 6 weeks<br>* Other names: Minocycline;|
| Placebo Comparator: Placebo<br>Placebo capsules twice a day | Drug: Placebo oral capsule<br>* Will be administered for 6 weeks<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | six weeks | 
| 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 | six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, adolescents, inflammation, anti-inflammatory