Anti-inflammatories and Adolescent Schizophrenia

NCT ID: NCT04020588

Last Updated: 2019-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2020-12-31

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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Celecoxib

Celecoxib 200 mg twice a day

Group Type ACTIVE_COMPARATOR

Celecoxib 200mg

Intervention Type DRUG

Will be administered for 6 weeks

Minocycline

Minocycline 100 mg twice a day

Group Type ACTIVE_COMPARATOR

Minocycline 100mg

Intervention Type DRUG

Will be administered for 6 weeks

Placebo

Placebo capsules twice a day

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Will be administered for 6 weeks

Interventions

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Celecoxib 200mg

Will be administered for 6 weeks

Intervention Type DRUG

Placebo oral capsule

Will be administered for 6 weeks

Intervention Type DRUG

Minocycline 100mg

Will be administered for 6 weeks

Intervention Type DRUG

Other Intervention Names

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Minocycline 100 mg Minocycline Placebo Minocycline

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Psiquiatrico Infantil

Mexico City, Ni Ee.uu. Ni Canadá, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Rosa Ulloa, M.D

Role: CONTACT

+525555739161

Facility Contacts

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Rosa E Ulloa, M.D.

Role: primary

5555739161

Other Identifiers

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II3/02/0618

Identifier Type: -

Identifier Source: org_study_id

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