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NCT00545675: SMART-M
Multi-center, Double-blind, Randomized, Comparative Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of Abilify and Depakote in 24-week Treatment of Mania in Patients With Bipolar Disorder Remitted After 6-week Treatment With Abilify and Depakote
Phase 4 trial testing Abilify(aripiprazole) in Bipolar Disorder in 146 participants. Completed in 1 July 2010.
1 July 2010
Quick facts
| Lead sponsor | Korea Otsuka Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 146 |
| Start date | 1 December 2007 |
| Primary completion | 1 July 2010 |
| Estimated completion | 1 July 2010 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Abilify(aripiprazole)
- Depakote (divalproate) — full drug profile →
Conditions studied
- Bipolar Disorder — all drugs for Bipolar Disorder →
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 65, 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.
-
Time to recurrence of bipolar disorder from randomization
Time frame: Throughout the study
Sponsor's own description
To demonstrate the difference between Abilify with Depakote vs. Placebo with Depakote in 24-week treatment in patients with remission status after Abilify with Depakote in the 6-week study of acute mania in patients with bipolar 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:
- PubMed search for NCT00545675
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Korea Otsuka Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
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- NCT04189705 — A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis · Phase 3 · completed
- NCT04150146 — To Evaluate Food Effect on the Pharmacokinetics of Rebamipide in Healthy Volunteers · Phase 1 · completed
- NCT03949894 — Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domI · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00545675 (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 Korea Otsuka Pharmaceutical Co., Ltd.
- Last refreshed: 10 August 2010
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/NCT00545675.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing