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Minocycline Augmentation in Schizophrenia

22. marts 2012 opdateret af: Mujeeb Shad, The University of Texas Health Science Center, Houston

Minocycline Augmentation in Early-Course Schizophrenia

This study aims to examine the efficacy of minocycline augmentation in a sample of moderately ill outpatients with early-course schizophrenia on their chlorpromazine-equivalent doses of second-generation antipsychotic medications. The investigators hypothesize that as compared to placebo a 2-month treatment with minocycline in 120 volunteers with early-course schizophrenia will result in a more significant improvement in psychopathology (primary outcome) and cognitive symptoms (secondary outcome). In addition, cytokine plasma levels will be used as another secondary outcome measure to see if treatment-induced changes in total PANSS score are associated with changes in cytokine levels.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Minocycline, which is a second-generation tetracycline, has been found to inhibit Nitric Oxide Synthase (NOS) and inflammatory cytokines. These are some of the primary mechanisms that have been proposed to explain its neuroprotective and neuroplastic effects in several animal and human models of neurological and psychiatric diseases, including Parkinson's disease and schizophrenia. There are only three clinical trials with minocycline in schizophrenia subjects. A more definitive clinical trial in a larger sample with optimized and cost-effective design using a comprehensive cognitive battery and a global assessment of schizophrenia symptom domains is necessary to examine the efficacy of minocycline. If minocycline improves psychopathology and potentially other symptoms (including cognitive function) for schizophrenia, the treatment could be easily implemented in the existing treatment delivery system at relatively low cost and have the potential for making a significant public health impact. The investigators plan to recruit 120 individuals with early course schizophrenia who are currently on second-generation antipsychotic (SGA) medications and are experiencing persistent symptoms in at least the moderate range. In an effort to limit placebo response, which is notoriously high in psychiatric population, the investigators are using an adaptive design. Since, there is growing evidence to support the inflammatory hypothesis of schizophrenia, the investigators will also explore whether cytokine levels mediate the response from minocycline treatment.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater, 77021
        • Rekruttering
        • Harris County Psychiatric Center
        • Kontakt:
        • Underforsker:
          • Adel Wasseff, M.D.
        • Ledende efterforsker:
          • Mujeeb U Shad, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 35 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Ages between 18-35 years
  2. Males & females
  3. Current DSM-IV diagnosis of schizophrenia or schizoaffective disorder confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.) conducted by a trained psychiatrist.
  4. Treatment with a stable dose of second generation antipsychotic medication for at least 1 months prior to study entry 200-600 mg/day chlorpromazine equivalent doses);
  5. Evidence of stable symptomatology for 12 weeks as evidenced by no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms, no ER use for symptoms of schizophrenia and no significant changes to antipsychotic medication or dose (>25%) in the past 12 weeks.
  6. Baseline total score between 40 and 65 on the Brief Psychiatric Rating Scale (BPRS);
  7. Raw score of 12 or higher on the Wechsler Test of Adult Reading (WTAR) (estimates premorbid IQ).
  8. Able to comprehend the procedure and aims of the study to provide informed consent

Exclusion Criteria:

  1. Acute, unstable, significant or untreated medical illness beside schizophrenia;
  2. Pregnant or breast-feeding females;
  3. History of substance abuse or dependence in the past 3 months.
  4. Known contraindication to minocycline treatment.
  5. Treatment with minocycline or Beta-lactam antibiotics in the preceding half year before study entry.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
EquivalentPlacebo will be given
Eksperimentel: Minocyclin
Medicin: Minocycline
Minocycline will be given orally at 200 mg a day for 4 months
Andre navne:
  • Minocin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment-induced change in total score on Positive and Negative Syndrome Scale (PANSS)
Tidsramme: Baseline, week 8, and week 16 of the study
PANSS total score will be used to examine treatment-induced change in psychaopthology. The PANSS is a 30-item rating scale used to assess symptoms of psychopathology. We will use the total PANSS score as the primary outcome measure which reflects total level of psychopathology including the positive and negative symptoms as well as general psychopathology.This measure will be administered at baseline, week 8 and week 16 of the study to assess if minocyline treatment results in a significant reduction in PANSS total score as opposed to placebo.
Baseline, week 8, and week 16 of the study

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment-induced change in MATRICS Cognitive Consensus Battery (MCCB)
Tidsramme: Baseline and week 16 of the study
Average total score on MCCB will be used to examine treatment-induced change in cognitive function. MCCB (Nuechterlein et al., 2008) will be admisnitered at the baseline an week 16 of the study. The MCCB assesses 7 domains of cognitive functioning known to be impaired for individuals with schizophrenia. A summary score averaging across domains is generated as a global measure of cognitive functioning.
Baseline and week 16 of the study
Treatment-induced changes in plasma level of cytokines
Tidsramme: Baseline and week 16 of the study
Cytokine levels will assessed at baseline and week 16 of the study to examine treatment-induced changes in neuroinflammation.
Baseline and week 16 of the study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Texas Health Science Center, Houston

Samarbejdspartnere

Stanley Medical Research Institute

Efterforskere

  • Ledende efterforsker: Mujeeb U Shad, MD, MSCS, UT Health Sciences Center at Houston

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2012

Primær færdiggørelse (Forventet)

1. januar 2015

Studieafslutning (Forventet)

1. januar 2015

Datoer for studieregistrering

Først indsendt

14. marts 2012

Først indsendt, der opfyldte QC-kriterier

22. marts 2012

Først opslået (Skøn)

23. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. marts 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. marts 2012

Sidst verificeret

1. marts 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HSC-MS-11-0201

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Minocycline

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Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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