Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study
29. januar 2014 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
15
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Long Beach, California, Forente stater, 90822
- Rekruttering
- VA Long Beach
-
Ta kontakt med:
- Susan Shakib, Pharm.D.
- Telefonnummer: 4564 562-826-8000
- E-post: susan.shakib@va.gov
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.
Andre navn:
All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
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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
|
|
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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)
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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
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At initial visit and at week 12 of the study
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2014
Primær fullføring (Forventet)
1. juli 2015
Datoer for studieregistrering
Først innsendt
8. oktober 2013
Først innsendt som oppfylte QC-kriteriene
9. oktober 2013
Først lagt ut (Anslag)
14. oktober 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
30. januar 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. januar 2014
Sist bekreftet
1. januar 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VALB-1259
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