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NCT00220636
Abilify (Aripiprazole) as an Adjunctive Treatment for Refractory Unipolar Depression
Phase 4 trial testing Aripiprazole in Depressive Disorder, Major in 15 participants. Completed in 1 January 2008.
1 March 2007
Quick facts
| Lead sponsor | St. Luke's-Roosevelt Hospital Center |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 1 March 2005 |
| Primary completion | 1 March 2007 |
| Estimated completion | 1 January 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Aripiprazole (aripiprazole) — full drug profile →
Conditions studied
- Depressive Disorder, Major — all drugs for Depressive Disorder, Major →
Sponsor
St. Luke's-Roosevelt Hospital Center
Who can join
Adults 18 to 70, any sex, with Depressive Disorder, Major. 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.
-
Hamilton Depression Rating Scale (HDRS)
Time frame: 12 weeks
Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (\>50% decrease) Remission (score\<=7) Outcome is the number of these subjects whose depression "responded"
Sponsor's own description
This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.
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 NCT00220636
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Aripiprazole
Trials testing the same drug.
- NCT06236451 — Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia · Phase 4 · completed
- NCT06060886 — Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis · Phase 4 · unknown
- NCT05554627 — VA Aripiprazole vs Esketamine for Treatment Resistant Depression · Phase 4 · withdrawn
- NCT05814640 — Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD) · Phase 1, PHASE2 · recruiting
- NCT05322031 — The Impact of Aripiprazole Long-acting on Myelin and Cognition in the Onset of Schizophrenia · Phase 4 · completed
Other recruiting trials for Depressive Disorder, Major
Currently open trials in the same condition.
- NCT07227454 — A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder · Phase 3 · recruiting
- NCT07258485 — A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major · recruiting
- NCT07059234 — The Motor Activity - Subjective Energy (MASE) Project · NA · recruiting
- NCT06982820 — Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia · NA · recruiting
- NCT05553353 — Dosing rTMS for Depression Post-SCI · NA · recruiting
Other St. Luke's-Roosevelt Hospital Center trials
Trials by the same sponsor.
- NCT02159807 — Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects · NA · completed
- NCT03195712 — Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers · completed
- NCT00841451 — Pulmonary Vein Isolation Outcomes With Fish Oils · no longer available
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 NCT00220636 (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 St. Luke's-Roosevelt Hospital Center
- Last refreshed: 26 April 2016
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/NCT00220636.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing