- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00394095
Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine
3 april 2013 uppdaterad av: Melissa Delbello, University of Cincinnati
A Double-Blind, Randomized, Placebo-Controlled, Pilot Study of Topiramate vs. Placebo in Combination With Olanzapine for the Prevention of Weight Gain in Manic or Mixed Youth With Bipolar Disorder
The primary objective of this study is to examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.
The secondary objective is to examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
After consent and screening, patients will be initiated on 5mg or 10mg per day of olanzapine.
Olanzapine doses will be titrated to 10-20 mg of olanzapine over one week, to a maximum of 20mg by day 21.
Patients will also receive either topiramate (25mg bid titrated over 18 days to 150 mg bid.
with flexibility to titrate to 200mg bid) or matched placebo.
Topiramate will be initiated at a dose of 25 mg bid and will be increased by 25 mg bid every three days as tolerated.
Patients will be evaluated by a blinded (to treatment status and adverse events) rater.
Studietyp
Interventionell
Inskrivning (Faktisk)
31
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45267-0559
- University of Cincinnati Medical Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
10 år till 18 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Male or female patients, ages 10-18 years.
- Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
- Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation.
- Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) bipolar disorder, type I and currently display an acute manic or mixed episode as determined by K-SADS (Geller et al 2000).
- Patients must have a baseline (day 0) Young Mania Rating Scale score of at least 16.
- Subjects should be fluent in English.
Exclusion Criteria:
- Female patients who are either pregnant or lactating.
- Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions.
- Any history of current or past diabetes that has been treated with pharmacological intervention.
- Neurological disorders including epilepsy, stroke, or severe head trauma.
- Clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices. Clinically abnormal ECG.
- Manic or mixed episode due to a general medical condition or substance-induced mania (DSM-IV-TR).
- Mental retardation (IQ <70).
- History of hypersensitivity to or intolerance of olanzapine or topiramate.
- Prior history of olanzapine or topiramate non-response or allergic reaction.
- DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months.
- Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within 30 days, or a baseline Children's Depression Rating Scale suicide score of >3).
- Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.
- Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants.
- Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.
- Major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Topiramate Group
Patients' initial dose of topiramate 25mg bid, which was titrated over 18 days to 150 mg bid (with flexibility to titrate to 200mg bid) as tolerated.
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Oral topiramate 300-400mg/day for 12 weeks
Andra namn:
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Placebo-jämförare: Placebo Group
Sugar pill
|
Matched placebo to Experimental arm
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Body Mass Index (BMI)
Tidsram: 12 weeks
|
For all participants, BMI was computed using Change in BMI [kg/m2 (weight/height2)] over 12 weeks from Baseline to Week 12.
|
12 weeks
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Change in Body Weight
Tidsram: 12 weeks
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For all participants, change in body weight in kg over 12 weeks from Baseline to Week 12.
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12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Tolerability of Topiramate
Tidsram: 12 weeks
|
To examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.
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12 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Melissa P DelBello, MD, University of Cincinnati
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2006
Primärt slutförande (Faktisk)
1 augusti 2009
Avslutad studie (Faktisk)
1 september 2009
Studieregistreringsdatum
Först inskickad
27 oktober 2006
Först inskickad som uppfyllde QC-kriterierna
27 oktober 2006
Första postat (Uppskatta)
31 oktober 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
4 april 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 april 2013
Senast verifierad
1 april 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- F1D-MC-X304
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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