A Phase 4 interventional study of Celecoxib 200mg and Placebo oral capsule in Schizophrenia, sponsored by Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico. Status unknown at 1 site in Mexico. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-09-03.
Sponsored by Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico · Phase 4, Interventional, and Treatment
A double-blind controlled trial assessing the efficacy of anti-inflammatories on symptoms and cognition of adolescents with schizophrenia
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 90 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Active infection
Celecoxib 200 mg twice a day
Drug: Celecoxib 200mg
Minocycline 100 mg twice a day
Drug: Minocycline 100mg
Placebo capsules twice a day
Drug: Placebo oral capsule
Will be administered for 6 weeks
Also known as: Minocycline 100 mg, Minocycline
Will be administered for 6 weeks
Also known as: Placebo
Will be administered for 6 weeks
Also known as: Minocycline
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
Time frame: 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.
Time frame: six weeks
Plan to share: No
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This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico