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Anti-inflammatories and Adolescent Schizophrenia

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ClinicalTrials.gov Identifier: NCT04020588
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Celecoxib 200mg Drug: Placebo oral capsule Drug: Minocycline 100mg Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Anti-inflammatory Treatments on the Symptoms, Cognition, and Functioning of Adolescents With Schizophrenia
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: Celecoxib
Celecoxib 200 mg twice a day
Drug: Celecoxib 200mg
Will be administered for 6 weeks
Other Names:
  • Minocycline 100 mg
  • Minocycline

Active Comparator: Minocycline
Minocycline 100 mg twice a day
Drug: Minocycline 100mg
Will be administered for 6 weeks
Other Name: Minocycline

Placebo Comparator: Placebo
Placebo capsules twice a day
Drug: Placebo oral capsule
Will be administered for 6 weeks
Other Name: Placebo




Primary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020588


Contacts
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Contact: Rosa Ulloa, M.D +525555739161 eulloa@hotmail.com

Locations
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Mexico
Hospital Psiquiatrico Infantil Recruiting
Mexico City, Ni Ee.uu. Ni Canadá, Mexico, 14080
Contact: Rosa E Ulloa, M.D.    5555739161    eulloa@hotmail.com   
Sponsors and Collaborators
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

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Responsible Party: Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
ClinicalTrials.gov Identifier: NCT04020588     History of Changes
Other Study ID Numbers: II3/02/0618
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico:
schizophrenia
adolescents
inflammation
anti-inflammatory
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Minocycline
Celecoxib
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents