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Bupropion

Phase 3

Major Depressive Disorder (MDD) | Small molecule | Psychiatry |GSK plc|Last Updated: Sep 25, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment845

FDA Designations

No designations recorded

Clinical trial landscape

Bupropion · 6 trials · 5 indications

Phase 3 5Phase 1 1
NCT00064467Lethargic Depression StudyEpilepsy
COMPLETED268 Analytics
NCT00051259Effects of Antidepressants on Sexual FunctioningMajor Depressive Disorder (MDD)
COMPLETED420 Analytics
NCT00051272Effects Of Antidepressants On Sexual Functioning In AdultsMajor Depressive Disorder (MDD)
COMPLETED425 Analytics
NCT00048360Attention-Deficit Hyperactivity Disorder (ADHD) Study With AdultsAttention Deficit Disorder
COMPLETED162 Analytics
NCT00046241Prevention of Seasonal Affective DisorderSeasonal Affective Disorder
COMPLETED300 Analytics
PHASE3COMPLETED
Lethargic Depression Study
EpilepsyUnlock trial analytics
PHASE3COMPLETED
Effects of Antidepressants on Sexual Functioning
Major Depressive Disorder (MDD)Unlock trial analytics
PHASE3COMPLETED
Effects Of Antidepressants On Sexual Functioning In Adults
Major Depressive Disorder (MDD)Unlock trial analytics
PHASE3COMPLETED
Attention-Deficit Hyperactivity Disorder (ADHD) Study With Adults
Attention Deficit DisorderUnlock trial analytics
PHASE3COMPLETED
Prevention of Seasonal Affective Disorder
Seasonal Affective DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated.
Percentage of subjects with orgasm dysfunction. Change in HAMD-17 total score.
Percent of subjects with orgasm dysfunction. Change from baseline in HAMD-17 total score.
ADHD Rating Scale
Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.
End of season depression-free rate.
7 months

Secondary Endpoints

Percent of responders. Percent of remitters. Quality of Life Enjoyment and Satisfaction Questionnaire.
Percent of subjects in remission, HAMD-17. Changes in Sexual Functioning Questionnaire. Percent of responders, HAMD-17 CGI-I and CGI-S.
Percent of subjects in remission, HAMD-17. Changes in Sexual functioning Questionnaire. CGI-I and CGI-S. Percent of responders, HAMD-17.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Extended-release Bupropion HydrochlorideOTHERExtended-release Bupropion Hydrochloride

Interventions

NameTypeDescription
Extended-release bupropion (HCl)DRUG -
Extended-Release Bupropion HydrochlorideDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion criteria: * Primary diagnosis of MDD with current duration lasting 12 weeks but no greater than 2 years. * Generally in good health. * Subject must read and write at a level sufficient to provide written informed consent. Exclusion criteria: * Current or past history of seizure disorder...

Countries:United StatesCanada
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Frequently asked questions about Bupropion

What is Bupropion used for?

Bupropion is an investigational small molecule being studied for psychiatric and neurological conditions, including Attention Deficit Disorder, Epilepsy, Major Depressive Disorder (MDD), Seasonal Affective Disorder, and Depressive Disorder. It is being developed by GSK plc (GSK) and is currently in Phase 1 clinical development.

Who makes Bupropion?

Bupropion is being developed by GSK plc, a pharmaceutical company traded under the ticker GSK. The drug is currently in Phase 1 clinical development for multiple psychiatric indications, including Major Depressive Disorder and Seasonal Affective Disorder.

What phase is Bupropion in?

Bupropion is in Phase 1 clinical development. It has completed a total of two clinical trials, both of which are finished, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials has Bupropion been in?

Bupropion has been studied in two completed clinical trials. One trial, NCT00046241, investigated prevention of Seasonal Affective Disorder with 300 participants. Another trial, NCT00048360, studied Attention-Deficit Hyperactivity Disorder in adults with 162 participants. Both trials were completed in the United States and Canada.

Is Bupropion the same as any other drug?

Bupropion is the drug name used in clinical trials for this investigational compound. No alternative names have been established for this drug in the available clinical trial data. It is being studied under the name Bupropion across all listed trials.