A Study of Aripiprazole in Patients With Major Depressive... | NCT00105196

NCT00105196

Status Module

Sponsor/Collaborators Module

Name	Class
Otsuka America Pharmaceutical	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
A1	Experimental		Drug: Aripiprazole+ ADT
A2	Placebo Comparator		Drug: Placebo+ ADT

Name	Type	Description	Arm Group Labels	Other Names
Aripiprazole+ ADT	Drug	Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks	A1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)	Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.	Baseline (Week 8) and Week 14

Secondary Outcomes

Measure	Description	Time Frame
Mean Change in Sheehan Disability Scale (SDS) Mean Score	Mean change from Week 8 (baseline) to Week 14 in SDS Mean Score, a 3-item, ordinal scale (0=unimpaired; 30=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.	Baseline (Week 8) and Week 14

Other Outcomes

Measure	Description	Time Frame
MADRS Response	Number of subjects with a ≥50 percent reduction from Week 8 (baseline) in MADRS Total Score, a 10-item, ordinal rating scale to assess the severity of depressive symptoms (0=no symptoms; 60=most severe symptoms).	Baseline (Week 8) and Week 14
Clinical Global Impression (CGI)-Improvement Response

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University Of Alabama At Birmingham		Birmingham	Alabama	35205	United States
Sharp Mesa Vista Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19407731	Background	Berman RM, Fava M, Thase ME, Trivedi MH, Swanink R, McQuade RD, Carson WH, Adson D, Taylor L, Hazel J, Marcus RN. Aripiprazole augmentation in major depressive disorder: a double-blind, placebo-controlled study in patients with inadequate response to antidepressants. CNS Spectr. 2009 Apr;14(4):197-206. doi: 10.1017/s1092852900020216.
24766999

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Aripiprazole + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Aripiprazole + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
BG001	Placebo + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00045.1± 10.6 BG00145.6± 11.3 BG00245.4± 10.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000138 BG001117 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0006 BG0016 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)

Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

Posted

Mean

Standard Error

units on a scale

Baseline (Week 8) and Week 14

ID	Title	Description
OG000	Aripiprazole + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
OG001	Placebo + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.

Units	Counts
Participants	OG000174 OG001169

Title

Denominators

Categories

Title	Measurements
	OG000-10.12± 0.74 OG001-6.39± 0.74

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The sample size for the study was based on the primary outcome measure. The study was powered at 90% to detect a treatment difference between adjunctive aripiprazole and adjunctive placebo of 3.75, assuming a standard deviation of 10.5 and a two-sided alpha level of 0.05. The null-hypothesis was the lack of a treatment difference.	t-test, 2 sided		<0.001		Mean Difference (Final Values)	-3.73				95	-5.44	-2.02				No	Superiority or Other

Secondary

Mean Change in Sheehan Disability Scale (SDS) Mean Score

Mean change from Week 8 (baseline) to Week 14 in SDS Mean Score, a 3-item, ordinal scale (0=unimpaired; 30=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

Posted

Mean

Standard Error

units on a scale

Baseline (Week 8) and Week 14

ID	Title	Description
OG000	Aripiprazole + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
OG001	Placebo + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.

Units	Counts
Participants	OG000

Secondary

Mean Change in SDS Item Score (Social Life)

Mean change from Week 8 (baseline) to Week 14 in SDS Social Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

Posted

Mean

Standard Error

units on a scale

Baseline (Week 8) and Week 14

ID	Title	Description
OG000	Aripiprazole + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
OG001	Placebo + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.

Units	Counts
Participants

Secondary

Mean Change in SDS Item Score (Family Life)

Mean change from Week 8 (Baseline) to Week 14 in SDS Family Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

Posted

Mean

Standard Error

units on a scale

Baseline (Week 8) and Week 14

ID	Title	Description
OG000	Aripiprazole + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
OG001	Placebo + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.

Units	Counts
Participants

Secondary

Mean Change in SDS Item Score (Work/School)

Mean change from Week 8 (baseline) to Week 14 in SDS Work/School Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.

Posted

Mean

Standard Error

units on a scale

Baseline (Week 8) and Week 14

ID	Title	Description
OG000	Aripiprazole + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
OG001	Placebo + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.

Units	Counts
Participants

Other Pre-specified

MADRS Response

Number of subjects with a ≥50 percent reduction from Week 8 (baseline) in MADRS Total Score, a 10-item, ordinal rating scale to assess the severity of depressive symptoms (0=no symptoms; 60=most severe symptoms).

Posted

Number

participants

Baseline (Week 8) and Week 14

ID	Title	Description
OG000	Aripiprazole + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
OG001	Placebo + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.

Units	Counts
Participants	OG000

Other Pre-specified

Clinical Global Impression (CGI)-Improvement Response

Number of subjects with response relative to Week 8 (baseline). Response defined as score of 1 (very much improved) or 2 (much improved) on a 7-point, ordinal scale (1=very much improved; 7=very much worse).

Posted

Number

Participants

Baseline (Week 8) and Week 14

ID	Title	Description
OG000	Aripiprazole + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
OG001	Placebo + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.

Units	Counts
Participants	OG000

Other Pre-specified

MADRS Remission

Number of subjects in remission. Remission defined as as MADRS Total Score of <10 at 14 weeks, and a reduction of ≥50 percent from Week 8 (baseline) in MADRS, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms).

Posted

Number

participants

Baseline (Week 8) and Week 14

ID	Title	Description
OG000	Aripiprazole + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
OG001	Placebo + ADT	Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Aripiprazole				1	176	107	176
EG001	Placebo				1	172	62	172

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA 11	Systematic Assessment		EG0000 affected176 at risk EG0011 affected172 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA 11	Systematic Assessment		EG0001 affected176 at risk EG0010 affected172 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
VISION BLURRED	Eye disorders	MedDRA 11	Systematic Assessment	EG00013 affected176 at risk EG0013 affected172 at risk
INSOMNIA	Psychiatric disorders	MedDRA 11	Systematic Assessment	EG00015 affected176 at risk EG0019 affected172 at risk
RESTLESSNESS	Psychiatric disorders	MedDRA 11	Systematic Assessment	EG00022 affected176 at risk EG0016 affected172 at risk
HEADACHE	Nervous system disorders	MedDRA 11	Systematic Assessment	EG00015 affected176 at risk EG00114 affected172 at risk
AKATHISIA	Nervous system disorders	MedDRA 11	Systematic Assessment	EG00032 affected176 at risk EG0016 affected172 at risk
DIZZINESS	Nervous system disorders	MedDRA 11	Systematic Assessment	EG0009 affected176 at risk EG0015 affected172 at risk
SOMNOLENCE	Nervous system disorders	MedDRA 11	Systematic Assessment	EG00010 affected176 at risk EG0011 affected172 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 11	Systematic Assessment	EG0007 affected176 at risk EG00110 affected172 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 11	Systematic Assessment	EG00010 affected176 at risk EG00113 affected172 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 11	Systematic Assessment	EG00010 affected176 at risk EG0016 affected172 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11	Systematic Assessment	EG00013 affected176 at risk EG00113 affected172 at risk
FATIGUE	General disorders	MedDRA 11	Systematic Assessment	EG00016 affected176 at risk EG0018 affected172 at risk

ID	Term
D003865	Depressive Disorder, Major
D012008	Recurrence

ID	Term
D000068180	Aripiprazole

Ancestor Terms

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms