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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004605-26-GB

Enrollment

Registered

2007-01-14

Start date

2007-08-23

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Ablify Product Name: Aripiprazole Pharmaceutical Form: Tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Ta

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Aims To investigate the effectiveness and tolerability of Aripiprazole as an add-on strategy in patients suffering from recurrent depressive disorder (DSMIV criteria) and not responding to an adequate dose of an antidepressant Primary Objectives -1- HAM-D17 (Hamilton rating scale for depression) 17-item clinician-rated scale that is designed to measure the severity of illness among patients already diagnosed with depression. -2- MADRS (Montogmery Asberg Depression Rating scale for severity) 10-item clinician-rated scale that focuses on severity of psychological symptoms and is designed to be sensitive to change over time. Thus it is particularly useful in identifying treatment effects. 3- Remission is defined as minimal or no symptoms as reflected by HAM-D17 total of 7 or less -4- Response rate is defined as at least 50% decrease from baseline to endpoint on HAM-D17 total score ;Secondary Objective: -1- CGI of severity (CGI-S) in the presence of the subject, to record the severity of the illness at the time of assessment, the score ranges from 1 (normal, not ill at all) to 7 (among the most extremely ill patients) -2- The patients Global Impression of improvement (PGI-improvement)- a patient-rated instrument that measures the improvement of the patient’s symptoms. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse) -3- To evaluate the incidence of adverse events during the study measured by spontaneously reported adverse events. ;Primary end point(s): - Remission is defined as minimal or no symptoms as reflected by HAM-D17 total of 7 or less - Response rate is defined as at least 50% decrease from baseline to endpoint on HAM-D17 total score	—

Measure

Time frame

Main Objective: Aims To investigate the effectiveness and tolerability of Aripiprazole as an add-on strategy in patients suffering from recurrent depressive disorder (DSMIV criteria) and not responding to an adequate dose of an antidepressant Primary Objectives -1- HAM-D17 (Hamilton rating scale for depression) 17-item clinician-rated scale that is designed to measure the severity of illness among patients already diagnosed with depression. -2- MADRS (Montogmery Asberg Depression Rating scale for severity) 10-item clinician-rated scale that focuses on severity of psychological symptoms and is designed to be sensitive to change over time. Thus it is particularly useful in identifying treatment effects. 3- Remission is defined as minimal or no symptoms as reflected by HAM-D17 total of 7 or less -4- Response rate is defined as at least 50% decrease from baseline to endpoint on HAM-D17 total score ;Secondary Objective: -1- CGI of severity (CGI-S) in the presence of the subject, to record the severity of the illness at the time of assessment, the score ranges from 1 (normal, not ill at all) to 7 (among the most extremely ill patients) -2- The patients Global Impression of improvement (PGI-improvement)- a patient-rated instrument that measures the improvement of the patient’s symptoms. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse) -3- To evaluate the incidence of adverse events during the study measured by spontaneously reported adverse events. ;Primary end point(s): - Remission is defined as minimal or no symptoms as reflected by HAM-D17 total of 7 or less - Response rate is defined as at least 50% decrease from baseline to endpoint on HAM-D17 total score

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026