Who is sponsoring NCT00150605?

NCT00150605 is sponsored by Validus Pharmaceuticals.

What drugs are being tested in NCT00150605?

Interventions in NCT00150605: Extended-release carbamazepine.

What condition does NCT00150605 study?

NCT00150605 studies Bipolar Disorder.

Is NCT00150605 still recruiting?

NCT00150605 is currently completed. Last updated 1 November 2007.

Last reviewed 2007-11-01 · How we verify

NCT00150605

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase IIIb, Open Label Observational Study of SPD417 Used in Combination With Other Psychotropic Medications for the Treatment of Bipolar I Disorder

Completed Phase 3 Last updated 1 November 2007

What this trial tests

Phase 3 trial testing Extended-release carbamazepine in Bipolar Disorder in 50 participants. Completed in 1 October 2005.

Timeline

1 February 2005

1 October 2005

Quick facts

Lead sponsor	Validus Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 February 2005
Estimated completion	1 October 2005

Drugs / interventions tested

Extended-release carbamazepine — full drug profile →

Conditions studied

Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Validus Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment

Sponsor's own description

The purpose of this study is to evaluate the safety of SPD417 when given with other psychotropic medications to treat bipolar I disorder.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Bipolar Disorder

Currently open trials in the same condition.

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NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
NCT07479758 — Biomarker Research on Ultra-High-Field MRI Combined With Visual Perception Assessment in the Diagnosis and Treatment Out · recruiting
NCT07140913 — A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Featur · Phase 3 · recruiting

Other Validus Pharmaceuticals trials

Trials by the same sponsor.

NCT02623504 — DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolar 1 Disorder · Phase 4 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00150605 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Validus Pharmaceuticals
Last refreshed: 1 November 2007

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00150605.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing