Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder
Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00854100
Collaborator
Gedeon Richter Ltd. (Industry)
231
41
3
17.2
5.6
0.3
Study Details
Study Description
Brief Summary
This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
231 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Placebo-Controlled Study of Cariprazine (RGH-188) As Adjunctive Therapy In Major Depressive Disorder
Actual Study Start Date
:
Jun 30, 2009
Actual Primary Completion Date
:
Dec 6, 2010
Actual Study Completion Date
:
Dec 6, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo |
Drug: Antidepressant + placebo
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
|
| Experimental: Cariprazine 0.1 - 0.3 mg Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose |
Drug: Antidepressant + cariprazine (0.1-0.3 mg/day)
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
|
| Experimental: Cariprazine 1.0 - 2.0 mg Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose |
Drug: Antidepressant + cariprazine (1-2 mg/d)
Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
|
Outcome Measures
Primary Outcome Measures
- Montgomery-Asberg Depression Rating Scale (MADRS) [Baseline (Week 8) to Week 16]
The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to and including Week 16.
Secondary Outcome Measures
- Clinical Global Impression - Improvement (CGI-I) [Week 16]
The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale that, in this study, will be used to rate total improvement or worsening of mental illness starting at Visit 2 (Week 2) and taken at every visit through Visit 11 (Week 16). The patient will be rated on a scale from 1 to 7, 1 indicating that the patient is very much improved and 7 indicating that the patient is very much worse. The secondary efficacy parameter was the CGI-I total score at Week 16.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Men and women, 18-65 years old
-
Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic features.
-
Previous failure to respond to adequate trials of one or two ADTs with less than 50% reduction in depressive symptoms during the present episode.
Exclusion Criteria:
- DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Forest Investigative Site 040 | Phoenix | Arizona | United States | 85050 |
| 2 | Forest Investigative Site 038 | Scottsdale | Arizona | United States | 85254 |
| 3 | Forest Investigative Site | Arcadia | California | United States | 91007 |
| 4 | Forest Investigative Site | Encino | California | United States | 91316 |
| 5 | Forest Investigative Site | Garden Grove | California | United States | 92845 |
| 6 | Forest Investigative Site | Irvine | California | United States | 92618 |
| 7 | Forest Investigative Site 013 | Los Alamitos | California | United States | 90720 |
| 8 | Forest Investigative Site 041 | National City | California | United States | 91950 |
| 9 | Forest Investigative Site | Oceanside | California | United States | 92056 |
| 10 | Forest Investigative Site 025 | Denver | Colorado | United States | 80239 |
| 11 | Forest Investigative Site | Norwich | Connecticut | United States | 06360 |
| 12 | Forest Investigative Site | Washington | District of Columbia | United States | 20016 |
| 13 | Forest Investigative Site 007 | Jacksonville | Florida | United States | 32216 |
| 14 | Forest Investigative Site 012 | West Palm Beach | Florida | United States | 33407 |
| 15 | Forest Investigative Site 033 | Atlanta | Georgia | United States | 30306 |
| 16 | Forest Investigative Site | Roswell | Georgia | United States | 30076 |
| 17 | Forest Investigative Site | Overland Park | Kansas | United States | 66211 |
| 18 | Forest Investigative Site 042 | Fall River | Massachusetts | United States | 02721 |
| 19 | Forest Investigative Site 034 | Pittsfield | Massachusetts | United States | 01267 |
| 20 | Forest Investigative Site | Omaha | Nebraska | United States | 68131 |
| 21 | Forest Investigative Site | Cherry Hill | New Jersey | United States | 08002 |
| 22 | Forest Investigative Site 001 | Bronx | New York | United States | 10467 |
| 23 | Forest Investigative Site 043 | Brooklyn | New York | United States | 11235 |
| 24 | Forest Investigative Site 020 | Mount Kisco | New York | United States | 10549 |
| 25 | Forest Investigative Site 039 | New York | New York | United States | 10003 |
| 26 | Forest Investigative Site 029 | New York | New York | United States | 10021 |
| 27 | Forest Investigative Site 032 | Raleigh | North Carolina | United States | 27607 |
| 28 | Forest Investigative Site | Canton | Ohio | United States | 44718 |
| 29 | Forest Investigative Site | Dayton | Ohio | United States | 45417 |
| 30 | Forest Investigative Site 015 | Portland | Oregon | United States | 97210 |
| 31 | Forest Investigative Site 006 | Media | Pennsylvania | United States | 19063 |
| 32 | Forest Investigative Site | Philadelphia | Pennsylvania | United States | 19104 |
| 33 | Forest Investigative Site | Philadelphia | Pennsylvania | United States | 19107 |
| 34 | Forest Investigative Site 023 | Memphis | Tennessee | United States | 38119 |
| 35 | Forest Investigative Site 031 | Memphis | Tennessee | United States | 38119 |
| 36 | Forest Investigative Site | Nashville | Tennessee | United States | 37212 |
| 37 | Forest Investigative Site | San Antonio | Texas | United States | 78229 |
| 38 | Forest Investigative Site | Woodstock | Vermont | United States | 05091 |
| 39 | Forest Investigative Site | Richmond | Virginia | United States | 23230 |
| 40 | Forest Investigative Site | Bellevue | Washington | United States | 98007 |
| 41 | Forest Investigative Site | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- Forest Laboratories
- Gedeon Richter Ltd.
Investigators
- Study Director: Robert Hayes, PhD, Forest Laboratories
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00854100
Other Study ID Numbers:
- RGH-MD-71
- NCT03605784
First Posted:
Mar 2, 2009
Last Update Posted:
Mar 5, 2019
Last Verified:
Feb 1, 2019
Keywords provided by Forest Laboratories
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | The randomized population for RGH-MD-71 totaled 231 participants |
| Arm/Group Title | Placebo | Cariprazine 0.1 - 0.3 mg | Cariprazine 1.0 - 2.0 mg |
|---|---|---|---|
| Arm/Group Description | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose |
| Period Title: Overall Study | |||
| STARTED | 81 | 76 | 74 |
| COMPLETED | 72 | 70 | 63 |
| NOT COMPLETED | 9 | 6 | 11 |
Baseline Characteristics
| Arm/Group Title | Placebo | Cariprazine 0.1 - 0.3 mg | Cariprazine 1.0 - 2.0 mg | Total |
|---|---|---|---|---|
| Arm/Group Description | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose | Total of all reporting groups |
| Overall Participants | 81 | 76 | 73 | 230 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
45.2
(10.2)
|
46.6
(11.7)
|
44.2
(12.1)
|
45.3
(11.3)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
61
75.3%
|
52
68.4%
|
51
69.9%
|
164
71.3%
|
| Male |
20
24.7%
|
24
31.6%
|
22
30.1%
|
66
28.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
7
8.6%
|
9
11.8%
|
9
12.3%
|
25
10.9%
|
| Not Hispanic or Latino |
74
91.4%
|
67
88.2%
|
64
87.7%
|
205
89.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
2
2.5%
|
0
0%
|
0
0%
|
2
0.9%
|
| Asian |
0
0%
|
2
2.6%
|
1
1.4%
|
3
1.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
10
12.3%
|
15
19.7%
|
11
15.1%
|
36
15.7%
|
| White |
69
85.2%
|
57
75%
|
60
82.2%
|
186
80.9%
|
| More than one race |
0
0%
|
2
2.6%
|
1
1.4%
|
3
1.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Montgomery-Asberg Depression Rating Scale (MADRS) |
|---|---|
| Description | The patient is rated on a scale from 0-6 on 10 items. Apparent sadness, reported sadness, lassitude, pessimistic thoughts, inner tension, suicidal thoughts, reduced sleep and appetite, concentration difficulties, inability to feel. The overall MADRS score ranges from 0-60, with 0 meaning no symptoms and score of 60 meaning maximum severity. The primary efficacy parameter was the change in MADRS score totals from the scores taken at Baseline (Week 8) and during at least one more time point up to and including Week 16. |
| Time Frame | Baseline (Week 8) to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 231 patients were randomized, and of them, 230 received at least 1 dose of treatment (Double-blind Safety Population), and had at least a baseline and 1 post-baseline MADRS assessment (Double-blind Intent To Treat Population). All patients in the Double-blind Intent To Treat Population were included in the efficacy analyses. |
| Arm/Group Title | Placebo | Cariprazine 0.1 - 0.3 mg | Cariprazine 1.0 - 2.0 mg |
|---|---|---|---|
| Arm/Group Description | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose |
| Measure Participants | 81 | 76 | 73 |
| Least Squares Mean (Standard Error) [Units on a Scale] |
-8.0
(1.0)
|
-7.5
(1.1)
|
-9.8
(1.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Cariprazine 0.1 - 0.3 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.746 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 0.5 | |
| Confidence Interval |
(2-Sided) 95% -2.4 to 3.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Cariprazine 1.0 - 2.0 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.227 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -1.8 | |
| Confidence Interval |
(2-Sided) 95% -4.8 to 1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Clinical Global Impression - Improvement (CGI-I) |
|---|---|
| Description | The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale that, in this study, will be used to rate total improvement or worsening of mental illness starting at Visit 2 (Week 2) and taken at every visit through Visit 11 (Week 16). The patient will be rated on a scale from 1 to 7, 1 indicating that the patient is very much improved and 7 indicating that the patient is very much worse. The secondary efficacy parameter was the CGI-I total score at Week 16. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 231 patients were randomized, and of them, 230 received at least 1 dose of treatment (Double-blind Safety Population), and had at least a baseline and 1 post-baseline MADRS assessment (Double-blind Intent To Treat Population). All patients in the Double-blind Intent To Treat Population were included in the efficacy analyses. |
| Arm/Group Title | Placebo | Cariprazine 0.1 - 0.3 mg | Cariprazine 1.0 - 2.0 mg |
|---|---|---|---|
| Arm/Group Description | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose |
| Measure Participants | 81 | 76 | 73 |
| Least Squares Mean (Standard Error) [Units on a Scale] |
2.5
(0.1)
|
2.5
(0.1)
|
2.3
(0.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Cariprazine 0.1 - 0.3 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.918 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 0.0 | |
| Confidence Interval |
(2-Sided) 95% -0.3 to 0.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Cariprazine 1.0 - 2.0 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.167 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | -0.2 | |
| Confidence Interval |
(2-Sided) 95% -0.6 to 0.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Up to 20 weeks | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Any AE includes the prospective ADT lead-in, double-blind treatment and 30 -day safety follow up will be considered a treatment-emergent adverse event (TEAE). A TEAE that occurs more than 30 days after the last dose of the investigational product will not be summarized for the safety follow-up period.1 patient left the study after they were randomized to the Cariprazine 1.0-2.0 mg arm, but never took the drug. Therefore, that patient is only captured in the lead in period data. | |||||||
| Arm/Group Title | Prospective Antidepressant-Therapy Lead In Period | Placebo | Cariprazine 0.1 - 0.3 mg | Cariprazine 1.0 - 2.0 mg | ||||
| Arm/Group Description | Interventions included: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) for 8 weeks prior to randomization | Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo for 8 weeks. AE reporting covers this 8 week period plus the 30 day safety follow up that proceeds it. | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine low dose for 8 weeks. AE reporting covers this 8 week period plus the 30 day safety follow up that proceeds it. | Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose for 8 weeks. AE reporting covers this 8 week period plus the 30 day safety follow up that proceeds it. | ||||
All Cause Mortality |
||||||||
| Prospective Antidepressant-Therapy Lead In Period | Placebo | Cariprazine 0.1 - 0.3 mg | Cariprazine 1.0 - 2.0 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/502 (0.2%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
Serious Adverse Events |
||||||||
| Prospective Antidepressant-Therapy Lead In Period | Placebo | Cariprazine 0.1 - 0.3 mg | Cariprazine 1.0 - 2.0 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/502 (1.8%) | 1/81 (1.2%) | 0/76 (0%) | 1/73 (1.4%) | ||||
| Cardiac disorders | ||||||||
| Angina Unstable | 0/502 (0%) | 1/81 (1.2%) | 0/76 (0%) | 0/73 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Hip Fracture | 1/502 (0.2%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Road Traffic Accident | 1/502 (0.2%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Upper Limb Fracture | 1/502 (0.2%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Intentional Overdose | 1/502 (0.2%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Nervous system disorders | ||||||||
| Convulsion | 1/502 (0.2%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Serotonin Syndrome | 1/502 (0.2%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Psychiatric disorders | ||||||||
| Anxiety | 1/502 (0.2%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Suicidal Ideation | 2/502 (0.4%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Depression | 1/502 (0.2%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Completed Suicide | 1/502 (0.2%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Alcohol Abuse | 1/502 (0.2%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Homicidal Ideation | 1/502 (0.2%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Suicide Attempt | 1/502 (0.2%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Chronic Obstructive Pulmanary Disease | 0/502 (0%) | 0/81 (0%) | 0/76 (0%) | 1/73 (1.4%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Prospective Antidepressant-Therapy Lead In Period | Placebo | Cariprazine 0.1 - 0.3 mg | Cariprazine 1.0 - 2.0 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 262/502 (52.2%) | 32/81 (39.5%) | 29/76 (38.2%) | 35/73 (47.9%) | ||||
| Gastrointestinal disorders | ||||||||
| Nausea | 70/502 (13.9%) | 5/81 (6.2%) | 5/76 (6.6%) | 5/73 (6.8%) | ||||
| Dry Mouth | 53/502 (10.6%) | 1/81 (1.2%) | 2/76 (2.6%) | 4/73 (5.5%) | ||||
| Constipation | 35/502 (7%) | 1/81 (1.2%) | 1/76 (1.3%) | 4/73 (5.5%) | ||||
| Diarrhoea | 36/502 (7.2%) | 5/81 (6.2%) | 4/76 (5.3%) | 3/73 (4.1%) | ||||
| General disorders | ||||||||
| Fatigue | 36/502 (7.2%) | 3/81 (3.7%) | 2/76 (2.6%) | 5/73 (6.8%) | ||||
| Infections and infestations | ||||||||
| Nasopharyngitis | 0/502 (0%) | 5/81 (6.2%) | 1/76 (1.3%) | 6/73 (8.2%) | ||||
| Upper Respiratory Tract Infection | 29/502 (5.8%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Increased appetite | 0/502 (0%) | 1/81 (1.2%) | 1/76 (1.3%) | 5/73 (6.8%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/502 (0%) | 1/81 (1.2%) | 4/76 (5.3%) | 1/73 (1.4%) | ||||
| Nervous system disorders | ||||||||
| Headache | 73/502 (14.5%) | 3/81 (3.7%) | 8/76 (10.5%) | 6/73 (8.2%) | ||||
| Dizziness | 31/502 (6.2%) | 7/81 (8.6%) | 4/76 (5.3%) | 6/73 (8.2%) | ||||
| Akathisia | 0/502 (0%) | 3/81 (3.7%) | 2/76 (2.6%) | 4/73 (5.5%) | ||||
| Tremor | 0/502 (0%) | 4/81 (4.9%) | 0/76 (0%) | 4/73 (5.5%) | ||||
| Psychiatric disorders | ||||||||
| Insomnia | 60/502 (12%) | 3/81 (3.7%) | 2/76 (2.6%) | 7/73 (9.6%) | ||||
| Anxiety | 0/502 (0%) | 3/81 (3.7%) | 1/76 (1.3%) | 4/73 (5.5%) | ||||
| Restlessness | 0/502 (0%) | 1/81 (1.2%) | 1/76 (1.3%) | 7/73 (9.6%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Hyperhidrosis | 25/502 (5%) | 0/81 (0%) | 0/76 (0%) | 0/73 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc
Results Point of Contact
| Name/Title | Therapeutic Area Head |
|---|---|
| Organization | Allergan, Inc |
| Phone | 877-277-8566 |
| IR-CTRegistration@allergan.com |
Responsible Party:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00854100
Other Study ID Numbers:
- RGH-MD-71
- NCT03605784
First Posted:
Mar 2, 2009
Last Update Posted:
Mar 5, 2019
Last Verified:
Feb 1, 2019