Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients

Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00139074

Enrollment

Registered

2005-08-31

Start date

2005-07-31

Completion date

2006-06-30

Last updated

2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61)

Brief summary

The primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14 days in non-responding patients after a 14 day initial treatment period with quetiapine. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Interventions

DRUGQuetiapine fumarate

oral variable dose

DRUGsodium valproate

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients suffering from a manic or mixed episode.

Exclusion criteria

* Patients who have not provided personal informed consent, * Known intolerance, hypersensitivity or lack of antimanic response to sodium valproate or quetiapine fumarate, * Involuntary admittance/detainment.

Design outcomes

Primary

Measure	Time frame
The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate)	after 2 weeks treatment

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026