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Anti-inflammatories and Adolescent Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Celecoxib 200mg
Placebo oral capsule
Minocycline 100mg
Sponsored by
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, adolescents, inflammation, anti-inflammatory

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Psiquiatrico InfantilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Celecoxib

Minocycline

Placebo

Arm Description

Celecoxib 200 mg twice a day

Minocycline 100 mg twice a day

Placebo capsules twice a day

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2019
Last Updated
August 29, 2019
Sponsor
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04020588
Brief Title
Anti-inflammatories and Adolescent Schizophrenia
Official Title
Effect of Anti-inflammatory Treatments on the Symptoms, Cognition, and Functioning of Adolescents With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, adolescents, inflammation, anti-inflammatory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib
Arm Type
Active Comparator
Arm Description
Celecoxib 200 mg twice a day
Arm Title
Minocycline
Arm Type
Active Comparator
Arm Description
Minocycline 100 mg twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules twice a day
Intervention Type
Drug
Intervention Name(s)
Celecoxib 200mg
Other Intervention Name(s)
Minocycline 100 mg, Minocycline
Intervention Description
Will be administered for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Placebo
Intervention Description
Will be administered for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Minocycline 100mg
Other Intervention Name(s)
Minocycline
Intervention Description
Will be administered for 6 weeks
Primary Outcome Measure Information:
Title
Symptom severity: Positive and Negative Syndrome Scale score
Description
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
Title
Cognition: MATRICS Consensus Cognitive Battery (MCCB) scores
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosa Ulloa, M.D
Phone
+525555739161
Email
eulloa@hotmail.com
Facility Information:
Facility Name
Hospital Psiquiatrico Infantil
City
Mexico City
State/Province
Ni Ee.uu. Ni Canadá
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa E Ulloa, M.D.
Phone
5555739161
Email
eulloa@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Anti-inflammatories and Adolescent Schizophrenia

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