Anti-inflammatories and Adolescent Schizophrenia
Effect of Anti-inflammatory Treatments on the Symptoms, Cognition, and Functioning of Adolescents With Schizophrenia
1 other identifier
interventional
90
1 country
1
Brief Summary
A double-blind controlled trial assessing the efficacy of anti-inflammatories on symptoms and cognition of adolescents with schizophrenia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 schizophrenia
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2019
CompletedFirst Submitted
Initial submission to the registry
July 12, 2019
CompletedFirst Posted
Study publicly available on registry
July 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedSeptember 3, 2019
August 1, 2019
1.3 years
July 12, 2019
August 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (3)
Celecoxib
ACTIVE COMPARATORCelecoxib 200 mg twice a day
Minocycline
ACTIVE COMPARATORMinocycline 100 mg twice a day
Placebo
PLACEBO COMPARATORPlacebo capsules twice a day
Interventions
Will be administered for 6 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Active infection
- Chronic somatic diseases, including autoimmune diseases
- Comorbidity with anorexia, substance use disorders
- Pregnancy
- Use of anti-inflammatory medications or antibiotics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Psiquiatrico Infantil
Mexico City, Ni Ee.uu. Ni Canadá, 14080, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2019
First Posted
July 16, 2019
Study Start
February 25, 2019
Primary Completion
June 1, 2020
Study Completion
December 1, 2020
Last Updated
September 3, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share