A Long-Term Study of Aripiprazole in Patients With Major Depressive Disorder
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ClinicalTrials.gov Identifier: NCT00095745 |
Recruitment Status :
Completed
First Posted : November 9, 2004
Last Update Posted : November 8, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Drug: Antidepressant + Aripiprazole | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1002 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Long-Term, Open-label, Study to Assess the Safety and Tolerability of Aripiprazole as an Adjunctive Therapy in the Treatment of Outpatients With Major Depressive Disorder |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | November 2007 |
Actual Study Completion Date : | November 2007 |

Arm | Intervention/treatment |
---|---|
No Intervention: Antidepressant + Aripiprazole |
Drug: Antidepressant + Aripiprazole
Antidepressant Caps/Tablets Aripiprazole Tablets, Oral, 2-30mg Aripiprazole, once daily, 52-weeks.
Other Name: Abilify |
- Safety assessments [ Time Frame: throughout the study ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women, 18 years or older
- Experiencing Major Depressive Disorder with a duration of minimally 8 weeks.
- Treatment history of an inadequate response to at least one and no more than four antidepressants

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095745

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Study Director, Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00095745 |
Other Study ID Numbers: |
CN138-164 |
First Posted: | November 9, 2004 Key Record Dates |
Last Update Posted: | November 8, 2013 |
Last Verified: | April 2011 |
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Aripiprazole Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Dopamine D2 Receptor Antagonists Dopamine Antagonists |