Clinical trial
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Name
16-243
Description
The objective of this retrospective observational study is to compare commonly prescribed bipolar disorder medications for their impact on: (1) hospitalization; (2) suicide attempts and self-harm; and (3) risk of drug-induced adverse effects such as kidney disease and diabetes mellitus. In addition, the investigators will examine heterogeneity of treatment effect by co-morbidity within pediatric, adult, and elderly sub-populations. Patient focus groups are convened to elicit additional questions and provide feedback on results.
Trial arms
Trial start
2016-09-01
Estimated PCD
2019-06-30
Trial end
2019-06-30
Status
Terminated
Treatment
Lithium Carbonate
Exposure to all dosages and delivery forms.
Other names:
Lithobid
Lamotrigine
Exposure to all dosages and delivery forms.
Other names:
Lamictal
Valproic Acid
Exposure to all dosages and delivery forms.
Other names:
Depakote, Valproate
Oxcarbazepine
Exposure to all dosages and delivery forms.
Other names:
Trileptal
Carbamazepine
Exposure to all dosages and delivery forms.
Other names:
Equetro
Ziprasidone
Exposure to all dosages and delivery forms.
Other names:
Geodon
Risperidone
Exposure to all dosages and delivery forms.
Other names:
Risperdal
Quetiapine
Exposure to all dosages and delivery forms.
Other names:
Seroquel
Olanzapine
Exposure to all dosages and delivery forms.
Other names:
Zyprexa
Aripiprazole
Exposure to all dosages and delivery forms.
Other names:
Abilify
Fluoxetine / Olanzapine
Exposure to all dosages and delivery forms.
Other names:
Symbyax
Haloperidol
Exposure to all dosages and delivery forms.
Other names:
Haldol Decanoate
Perphenazine
Exposure to all dosages and delivery forms.
Other names:
Trilafon
Clozapine
Exposure to all dosages and delivery forms.
Other names:
Clozaril
Asenapine
Exposure to all dosages and delivery forms.
Other names:
Saphris
Lurasidone
Exposure to all dosages and delivery forms.
Other names:
Latuda
Paliperidone
Exposure to all dosages and delivery forms.
Other names:
Invega
Mirtazapine
Exposure to all dosages and delivery forms.
Other names:
Remeron, Remeronsoltab
Bupropion
Exposure to all dosages and delivery forms.
Other names:
Zyban, Aplenzin, Wellbutrin
Desvenlafaxine
Exposure to all dosages and delivery forms.
Other names:
Pristiq, Desfax
Duloxetine
Exposure to all dosages and delivery forms.
Other names:
Cymbalta, Irenka
Venlafaxine
Exposure to all dosages and delivery forms.
Other names:
Effexor XR
Citalopram
Exposure to all dosages and delivery forms.
Other names:
Celexa
Escitalopram
Exposure to all dosages and delivery forms.
Other names:
Lexapro
Fluoxetine
Exposure to all dosages and delivery forms.
Other names:
Prozac, Sarafem
Fluvoxamine
Exposure to all dosages and delivery forms.
Other names:
Faverin, Fevarin, Floxyfral, Dumyrox, Luvox
Paroxetine
Exposure to all dosages and delivery forms.
Other names:
Paxil, Seroxat
Sertraline
Exposure to all dosages and delivery forms.
Other names:
Zoloft
Vilazodone
Exposure to all dosages and delivery forms.
Other names:
Viibryd
Doxepin
Exposure to all dosages and delivery forms.
Other names:
Sinequan, Silenor
Size
1037352
Primary endpoint
Risk of hospitalization
0-7 years
Risk of suicide and self-harm
0-7 years
Eligibility criteria
Inclusion Criteria:
* Two or more instances of bipolar disorder diagnoses within administrative claims records
Exclusion Criteria:
* Patients with less than 1 year of history in the database
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 1037352, 'type': 'ACTUAL'}}
Updated at
2024-03-12
1 organization
29 products
1 drug
1 indication
Organization
University of New MexicoProduct
Lithium CarbonateIndication
Bipolar DisorderProduct
LamotrigineProduct
Valproic AcidProduct
OxcarbazepineProduct
CarbamazepineProduct
ZiprasidoneProduct
RisperidoneProduct
QuetiapineDrug
OlanzapineProduct
AripiprazoleProduct
Fluoxetine + OlanzapineProduct
HaloperidolProduct
PerphenazineProduct
ClozapineProduct
AsenapineProduct
LurasidoneProduct
PaliperidoneProduct
MirtazapineProduct
BupropionProduct
DesvenlafaxineProduct
DuloxetineProduct
VenlafaxineProduct
CitalopramProduct
EscitalopramProduct
FluoxetineProduct
FluvoxamineProduct
ParoxetineProduct
SertralineProduct
VilazodoneProduct
Doxepin