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Trial record 38 of 229 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )

Incomplete Response in Late Life Depression: Getting to Remission (IRL GREY) (IRL GREY)

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ClinicalTrials.gov Identifier: NCT00892047
Recruitment Status : Completed
First Posted : May 4, 2009
Results First Posted : December 17, 2015
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Charles Reynolds, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: venlafaxine XR plus aripiprazole
Drug: venlafaxine plus placebo
Enrollment 468
Recruitment Details Participants were recruited at 3 Centers (University of Pittsburgh, Centre for Addiction and Mental Health in Toronto, Canada, and Washington University). The first participant was enrolled July 2009, last finished August 2014.
Pre-assignment Details 468 signed consent. 181 were randomized. Of these 181, 91 randomized to venlafaxine plus aripirazol and 90 to venlafaxine plus placebo. Prior to randomization, 191 responded to venlafaxine; 40 withdrew consent; 41 withdrawn by PI, possible AE, 14 non-compliance; 1 death.
Arm/Group Title 1: Venlafaxine Plus Aripiprazole 2: Placebo Comparator
Hide Arm/Group Description

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks.

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks.

Period Title: Overall Study
Started 91 90
Completed 87 83
Not Completed 4 7
Reason Not Completed
Adverse Event             2             2
subject burden             2             3
Lack of Efficacy             0             2
Arm/Group Title 1: Venlafaxine Plus Aripiprazole 2: Placebo Comparator Total
Hide Arm/Group Description

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks.

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 91 90 181
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 91 participants 90 participants 181 participants
66.4
(62.8 to 71.6)
65.7
(62.8 to 69.8)
66.0
(62.8 to 70.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 90 participants 181 participants
Female
52
  57.1%
51
  56.7%
103
  56.9%
Male
39
  42.9%
39
  43.3%
78
  43.1%
1.Primary Outcome
Title Percentage of Subjects Who Met Criteria for Remission Based on the Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten item instrument assessing depression symptoms. Possible scores range from 0-60; higher scores indicate greater severity of depression. Remission defined as score of 10 or less based on the MADRS.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1: Venlafaxine Plus Aripiprazole 2: Placebo Comparator
Hide Arm/Group Description:

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine XR plus aripiprazole: Dosage of venlafaxine ranged from 150mg to 300mg. Dose of aripirpazole ranged from 2mg to 15mg. Subject remained on venlafaxine throughout the 36 week study. Subject remained on aripiprazole or placebo for up to 24 weeks.

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine XR plus aripiprazole: Dosage of venlafaxine ranged from 150mg to 300mg. Dose of aripirpazole ranged from 2mg to 15mg. Subject remained on venlafaxine throughout the 36 week study. Subject remained on aripiprazole or placebo for up to 24 weeks.

Overall Number of Participants Analyzed 91 90
Measure Type: Number
Unit of Measure: percentage of participants
44 29
2.Primary Outcome
Title Akathisia
Hide Description Percentage of participants who developed clinically significant akathisia.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1: Venlafaxine Plus Aripiprazole 2: Placebo Comparator
Hide Arm/Group Description:

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks.

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks.

Overall Number of Participants Analyzed 91 90
Measure Type: Number
Unit of Measure: percentage of participants
26.7 12.2
3.Primary Outcome
Title Weight
Hide Description Weight change in kilograms
Time Frame Baseline through12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is lower due to missing data attributable to dropouts. The information obtained is from figure 3B in the manuscript
Arm/Group Title 1: Venlafaxine Plus Aripiprazole 2: Placebo Comparator
Hide Arm/Group Description:

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks.

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks.

Overall Number of Participants Analyzed 84 85
Mean (Standard Deviation)
Unit of Measure: kilograms
1.93  (3.00) 0.01  (3.15)
4.Primary Outcome
Title Parkinsonism
Hide Description Percentage of participants who develop signs of parkinsonism
Time Frame 12weeks
Hide Outcome Measure Data
Hide Analysis Population Description
We have a lower number of participants analyzed due to dropouts and missed assessments.
Arm/Group Title 1: Venlafaxine Plus Aripiprazole 2: Placebo Comparator
Hide Arm/Group Description:

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks.

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks.

Overall Number of Participants Analyzed 86 81
Measure Type: Number
Unit of Measure: percentage of participants
17.4 2.5
5.Secondary Outcome
Title Emergent Suicidal Ideation in Those With no Ideation at the Start of Treatment
Hide Description percentage of participants who reported suicidal ideation during treatment but not at baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
It is a smaller number of participants restricted to those who did not report any suicidal ideation at baseline. This is in Table 3of the manuscript
Arm/Group Title 1: Venlafaxine Plus Aripiprazole 2: Placebo Comparator
Hide Arm/Group Description:

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks.

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks.

Overall Number of Participants Analyzed 61 65
Measure Type: Number
Unit of Measure: percent of participants
21.3 29.2
6.Secondary Outcome
Title QTc Prolongation on EKG (to Greater or Equal to 480 Msec)
Hide Description percentage of participants
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
We had a smaller number of participant observations due to dropouts and missing data. This data is in Table 3 of the manuscript.
Arm/Group Title 1: Venlafaxine Plus Aripiprazole 2: Placebo Comparator
Hide Arm/Group Description:

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks.

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks.

Overall Number of Participants Analyzed 78 79
Measure Type: Number
Unit of Measure: percent of participants
1.3 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1: Venlafaxine Plus Aripiprazole 2: Placebo Comparator
Hide Arm/Group Description

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks.

antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo

venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks.

All-Cause Mortality
1: Venlafaxine Plus Aripiprazole 2: Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1: Venlafaxine Plus Aripiprazole 2: Placebo Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/91 (4.40%)      2/90 (2.22%)    
Cardiac disorders     
hospitalization for MI or CHF   1/91 (1.10%)  1 1/90 (1.11%)  1
Gastrointestinal disorders     
diverticulitis or excessive vonmiting   1/91 (1.10%)  1 1/90 (1.11%)  1
Nervous system disorders     
stroke   1/91 (1.10%)  1 0/90 (0.00%)  0
Psychiatric disorders     
completed suicide   1/91 (1.10%)  1 0/90 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1: Venlafaxine Plus Aripiprazole 2: Placebo Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/91 (0.00%)      0/90 (0.00%)    
limited number of participants older than 75, or members of racial/ethnic minority groups; limited follow-up period
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Charles F. Reynolds III, MD
Organization: University of Pittsburgh
Phone: 412-246-6414
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charles Reynolds, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00892047     History of Changes
Other Study ID Numbers: MH083660-01A1
First Submitted: April 29, 2009
First Posted: May 4, 2009
Results First Submitted: December 16, 2015
Results First Posted: December 17, 2015
Last Update Posted: December 17, 2015