Recent Updates
Recently added Catalysts

divalproex

Phase 3

Bipolar Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Jan 4, 2013

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment710

FDA Designations

No designations recorded

Clinical trial landscape

divalproex · 3 trials · 3 indications

Phase 3 3
NCT00114686Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar DisorderBipolar I Disorder
COMPLETED350 Analytics
NCT00107731Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I DisorderBipolar I Disorder
COMPLETED710 Analytics
NCT00081380Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I DisorderBipolar Disorder
COMPLETED710 Analytics
PHASE3COMPLETED
Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder
Bipolar I DisorderUnlock trial analytics
PHASE3COMPLETED
Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Bipolar I DisorderUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
Bipolar DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.

Secondary Endpoints

Change in the mean number of standardized drinks per day from Baseline to Week 12 & to monthly intervals, as derived from the TLFB scale
Change in manic symptoms as assessed by the change from Baseline to each visit in the Young Mania Rating Scale (YMRS) total score
Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Quetiapine fumarateDRUG -
lithiumDRUG -
divalproexDRUG -
Seroquel®, quetiapine fumarate (atypical antipsychotic)DRUG -
lithium (mood stabilizer)DRUG -
divalproex (mood stabilizer)DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range21 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Meets criteria for Bipolar I Disorder with Alcohol dependence * Outpatient Status * Recent history of heavy drinking Exclusion Criteria: * Unstable medical illness * Recent antipsychotic use * Poorly controlled Diabetes Mellitus or Diabetes related illness

Countries:United StatesAustraliaBelgiumBulgariaCzechiaFinlandFranceGermanyHungaryItalyNorwayPolandRussiaSouth AfricaSpainSwedenTurkey (Türkiye)United KingdomCanada
Unlock Eligibility Criteria

Frequently asked questions about divalproex

What is divalproex used for in bipolar disorder?

Divalproex is an investigational small molecule being studied for the maintenance treatment of Bipolar I Disorder. It is evaluated in combination with quetiapine fumarate (Seroquel) in Phase 3 clinical trials. The drug is intended for adult patients aged 18 years and older with bipolar disorder.

Who makes divalproex?

Divalproex is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety in patients with Bipolar I Disorder.

What phase is divalproex in?

Divalproex is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total enrollment of 1,060 patients across multiple countries.

What clinical trials is divalproex in?

Divalproex has been studied in two completed Phase 3 trials: NCT00081380 and NCT00107731, both evaluating its efficacy and safety in the maintenance of Bipolar I Disorder. A third trial, NCT00114686, examined quetiapine fumarate in alcohol dependency among bipolar patients. All trials were randomized and double-blind.

What does divalproex target?

Divalproex is a small molecule developed for the treatment of Bipolar I Disorder. The specific molecular target of divalproex is not disclosed in the available clinical trial information. The trials focus on its use as an adjunct to quetiapine fumarate for maintenance therapy in bipolar disorder patients.