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Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study

29. januar 2014 opdateret af: Charles Nguyen, Southern California Institute for Research and Education
The purpose of this study is to determine whether lorcaserin is effective for weight reduction in patients with weight gain as a result of antipsychotic medications.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

15

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Long Beach, California, Forenede Stater, 90822
        • Rekruttering
        • VA Long Beach
        • Kontakt:

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

INCLUSION CRITERIA:

  • Patients currently on atypical antipsychotics
  • The patient's BMI is greater than or equal to 30 kg/m2 OR the patient's BMI is greater than or equal to 27 kg/m2 in the presence of at least one weight-related co-morbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, metabolic syndrome, obstructive sleep apnea, or degenerative joint disease such as osteoarthritis.
  • Patient agreeable to follow up with provider at the scheduled appointments at week 1, week 2, week 4, week 8, week 12 and week 16 after initiation of medication.

EXCLUSION CRITERIA:

  • Pregnancy in women or breastfeeding
  • The patient has greater than mild aortic valve regurgitation, or moderate to greater mitral valve regurgitation
  • Known hypersensitivity to lorcaserin
  • The patient is taking another weight loss medication concurrently
  • Dementia
  • Age less than 18 or greater than 65
  • No recent substance abuse within 3 months
  • No suicidal ideation within 3 months
  • Unable to give informed consent, unless patient is conserved, then the conservator can provide informed consent

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lorcaserin with intensive diet counseling
Patients will be taking lorcaserin 10mg tablet by mouth twice daily. In addition, patients will be provided with intensive dietary counseling to promote weight loss.
Medicin: lorcaserin
Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.
Andre navne:
  • Belviq
Adfærdsmæssigt: Intensive dietary counseling
All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight loss
Tidsramme: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
The primary objective of this study is to evaluate the effectiveness of lorcaserin for weight loss management in patients on an antipsychotic agent. Will monitor the weight of the patient for evaluation.
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of glucose control
Tidsramme: At initial visit and at week 12 of the study
Will evaluate lab values for fasting blood glucose, Hemoglobin A1c, and fasting insulin levels
At initial visit and at week 12 of the study
Evaluation of cravings
Tidsramme: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Using various questionnaires to evaluate cravings of various foods.
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Monitoring of mood
Tidsramme: At initial visit, then at week 4 and week 12 of the study
Using standard questionnaires to evaluate mental health.
At initial visit, then at week 4 and week 12 of the study
Evaluation of systolic blood pressure
Tidsramme: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of diastolic blood pressure
Tidsramme: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of pulse
Tidsramme: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of body-mass index (BMI)
Tidsramme: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of waist circumference
Tidsramme: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Evaluation of cholesterol control
Tidsramme: At initial visit and at week 12 of the study
Will measure fasting cholesterol labs, which will include total cholesterol, triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL)
At initial visit and at week 12 of the study
Evaluation of electrolytes
Tidsramme: At initial visit and at week 12 of the study
Will monitor basic metabolic panel
At initial visit and at week 12 of the study
Evaluation of liver
Tidsramme: At initial visit and at week 12 of the study
Will monitor liver enzymes
At initial visit and at week 12 of the study
Evaluation of blood count
Tidsramme: At initial visit and at week 12 of the study
Will monitor blood count
At initial visit and at week 12 of the study

Samarbejdspartnere og efterforskere

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

Sponsor

Southern California Institute for Research and Education

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. januar 2014

Primær færdiggørelse (Forventet)

1. juli 2015

Datoer for studieregistrering

Først indsendt

8. oktober 2013

Først indsendt, der opfyldte QC-kriterier

9. oktober 2013

Først opslået (Skøn)

14. oktober 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. januar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VALB-1259

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 Vægtøgning

Kliniske forsøg med lorcaserin

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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