Proposal to investigate the efficacy and tolerability of Aripiprazole as an add-on therapy in patients not responding to an adequate dose of an antidepressant therapy

Phase 1

• Conditions: Depressive disorder not responding to an adequate dose of an antidepressant; MedDRA version: 8.1Level: LLTClassification code 10025470Term: Major depressive disorder, single episode, unspecified degree

• Registration Number: EUCTR2006-004605-26-GB
• Lead Sponsor: Manchester Mental Health &Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-14
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

-Meets criteria for Major depressive disorder by DSM IV
-Currently on an adequate dose (within BNF limits) of an antidepressant for at least 6 weeks with and/or other augmentation therapy including lithium and carbamezepine but not antipsychotic medication
-Have Hamilton Depression rating Scale (HAMD17) total score of >15
- Agrees to use an effective form of contraception throughout the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Pregnant
- DSM IV defined history of substance abuse or dependence within the past year
-Unstable medical illness (e.g., cardiovascular, liver, kidney, respiratory, endocrine, or neurological disease, including uncontrolled seizure disorder)
-History of or current psychotic features
- Patients should not have been on an antipsychotic medication in the past 2 weeks
-Patients who are receiving psychotherapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified