Back to resultsEfficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cariprazine
Placebo
Antidepressant Therapy (ADT)
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- Patients who have provided consent prior to any specific procedure
- Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
- Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2
Exclusion Criteria:
- Patients who do not meet DSM-IV-TR criteria for MDD
Sites / Locations
- Forest Investigative Site 032
- Forest Investigative Site 018
- Forest Investigative Site 029
- Forest Investigative Site 084
- Forest Investigative Site 085
- Forest Investigative Site 082
- Forest Investigative Site 022
- Forest Investigative Site 004
- Forest Investigative Site 090
- Forest Investigative Site 078
- Forest Investigative Site 080
- Forest Investigative Site 007
- Forest Investigative Site 054
- Forest Investigative Site 031
- Forest Investigative Site 048
- Forest Investigative Site 037
- Forest Investigative Site 053
- Forest Investigative Site 023
- Forest Investigative Site 071
- Forest Investigative Site 006
- Forest Investigative Site 026
- Forest Investigative Site 075
- Forest Investigative Site 027
- Forest Investigative Site 074
- Forest Investigative Site 036
- Forest Investigative Site 051
- Forest Investigative Site 044
- Forest Investigative Site 008
- Forest Investigative Site 019
- Forest Investigative Site 060
- Forest Investigative Site 024
- Forest Investigative Site 017
- Forest Investigative Site 047
- Forest Investigative Site 070
- Forest Investigative Site 013
- Forest Investigative Site 063
- Forest Investigative Site 062
- Forest Investigative Site 072
- Forest Investigative Site 010
- Forest Investigative Site 068
- Forest Investigative Site 061
- Forest Investigative Site 042
- Forest Investigative Site 065
- Forest Investigative Site 073
- Forest Investigative Site 049
- Forest Investigative Site 077
- Forest Investigative Site 012
- Forest Investigative Site 046
- Forest Investigative Site 045
- Forest Investigative Site 086
- Forest Investigative Site 014
- Forest Investigative Site 058
- Forest Investigative Site 076
- Forest Investigative Site 028
- Forest Investigative Site 016
- Forest Investigative Site 083
- Forest Investigative Site 025
- Forest Investigative Site 050
- Forest Investigative Site 067
- Forest Investigative Site 088
- Forest Investigative Site 089
- Forest Investigative Site 011
- Forest Investigative Site 015
- Forest Investigative Site 055
- Forest Investigative Site 066
- Forest Investigative Site 064
- Forest Investigative Site 035
- Forest Investigative Site 038
- Forest Investigative Site 039
- Forest Investigative Site 003
- Forest Investigative Site 052
- Forest Investigative Site 059
- Forest Investigative Site 001
- Forest Investigative Site 079
- Forest Investigative Site 005
- Forest Investigative Site 087
- Forest Investigative Site 069
- Forest Investigative Site 030
- Forest Investigative Site 041
- Forest Investigative Site 081
- Forest Investigative Site 043
- Forest Investigative Site 056
- Forest Investigative Site 057
- Forest Investigative Site 033
- Forest Investigative Site 034
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Placebo Comparator
Experimental
Other
Arm Label
Placebo + ADT Lead-in
Placebo + ADT (Double-Blind)
Cariprazine + ADT (Double-Blind)
Placebo + ADT (Continued Treatment)
Arm Description
Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.
Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).
Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).
Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.
Outcomes
Primary Outcome Measures
Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period
The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period
The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60. A negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.
Secondary Outcome Measures
Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period
The Sheehan Disability Scale (SDS) is a 3-item patient-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum from 0 (no impairment) to 10 (most severe). The 3 individual scores are summed for a total possible score of 0 (unimpaired) to 30 (highly impaired). A negative change from Baseline indicates improvement. MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.
Full Information
NCT ID
NCT01715805
First Posted
October 25, 2012
Last Updated
August 23, 2019
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01715805
Brief Title
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
Official Title
A Phase 3, Double-Blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2012 (Actual)
Primary Completion Date
June 24, 2016 (Actual)
Study Completion Date
June 24, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MDD, Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1022 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo + ADT Lead-in
Arm Type
Other
Arm Description
Antidepressant therapy (ADT) as prescribed by the investigator plus single-blind placebo for 8 weeks.
Arm Title
Placebo + ADT (Double-Blind)
Arm Type
Placebo Comparator
Arm Description
Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to dose-matched placebo, once per day, oral administration plus ADT for 8 weeks (up to Week 16).
Arm Title
Cariprazine + ADT (Double-Blind)
Arm Type
Experimental
Arm Description
Following the 8 week ADT plus single blind placebo lead-in period participants were randomized to cariprazine, 1.5 to 4.5 milligrams (mg) per day, oral administration plus ADT for 8 weeks (up to Week 16).
Arm Title
Placebo + ADT (Continued Treatment)
Arm Type
Other
Arm Description
Following the 8 week ADT plus single blind placebo lead-in period, participants who were ADT responders continued treatment with ADT plus placebo for an additional 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Intervention Description
Cariprazine capsules 1.5 to 4.5 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose-matched placebo capsule once per day
Intervention Type
Drug
Intervention Name(s)
Antidepressant Therapy (ADT)
Intervention Description
ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period
Description
The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60.
Time Frame
Baseline (Week 8)
Title
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period
Description
The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60. A negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.
Time Frame
Baseline (Week 8) to Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period
Description
The Sheehan Disability Scale (SDS) is a 3-item patient-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum from 0 (no impairment) to 10 (most severe). The 3 individual scores are summed for a total possible score of 0 (unimpaired) to 30 (highly impaired). A negative change from Baseline indicates improvement. MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.
Time Frame
Baseline (Week 8) to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have provided consent prior to any specific procedure
Meet the The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for Major Depressive Disorder (MDD)
Have a minimum score of 20 on 17-Item Hamilton Depression (HAMD-17) rating scale at Visits 1 and 2
Exclusion Criteria:
Patients who do not meet DSM-IV-TR criteria for MDD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willie Earley, MD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 032
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Forest Investigative Site 018
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Forest Investigative Site 029
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Forest Investigative Site 084
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Forest Investigative Site 085
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Forest Investigative Site 082
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Forest Investigative Site 022
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Forest Investigative Site 004
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site 090
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Forest Investigative Site 078
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Forest Investigative Site 080
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Forest Investigative Site 007
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Forest Investigative Site 054
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Forest Investigative Site 031
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Forest Investigative Site 048
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Forest Investigative Site 037
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Forest Investigative Site 053
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Forest Investigative Site 023
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Forest Investigative Site 071
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Forest Investigative Site 006
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Forest Investigative Site 026
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Forest Investigative Site 075
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Forest Investigative Site 027
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Forest Investigative Site 074
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Forest Investigative Site 036
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Forest Investigative Site 051
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Forest Investigative Site 044
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Forest Investigative Site 008
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Forest Investigative Site 019
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Forest Investigative Site 060
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Forest Investigative Site 024
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Forest Investigative Site 017
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Forest Investigative Site 047
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080-6315
Country
United States
Facility Name
Forest Investigative Site 070
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Forest Investigative Site 013
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Forest Investigative Site 063
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Forest Investigative Site 062
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Forest Investigative Site 072
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Forest Investigative Site 010
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Forest Investigative Site 068
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Forest Investigative Site 061
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Forest Investigative Site 042
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Forest Investigative Site 065
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Forest Investigative Site 073
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Forest Investigative Site 049
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Forest Investigative Site 077
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Forest Investigative Site 012
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Forest Investigative Site 046
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Forest Investigative Site 045
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
Facility Name
Forest Investigative Site 086
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Forest Investigative Site 014
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Forest Investigative Site 058
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Forest Investigative Site 076
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Forest Investigative Site 028
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Facility Name
Forest Investigative Site 016
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Forest Investigative Site 083
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Forest Investigative Site 025
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Forest Investigative Site 050
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Forest Investigative Site 067
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Forest Investigative Site 088
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Forest Investigative Site 089
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Forest Investigative Site 011
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Forest Investigative Site 015
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Forest Investigative Site 055
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Forest Investigative Site 066
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Forest Investigative Site 064
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Forest Investigative Site 035
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Forest Investigative Site 038
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Forest Investigative Site 039
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Forest Investigative Site 003
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Forest Investigative Site 052
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Forest Investigative Site 059
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Forest Investigative Site 001
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Forest Investigative Site 079
City
Austin
State/Province
Texas
ZIP/Postal Code
78732
Country
United States
Facility Name
Forest Investigative Site 005
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Forest Investigative Site 087
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Forest Investigative Site 069
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Forest Investigative Site 030
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Forest Investigative Site 041
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Forest Investigative Site 081
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site 043
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Forest Investigative Site 056
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
Forest Investigative Site 057
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Forest Investigative Site 033
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Forest Investigative Site 034
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
30618475
Citation
Earley WR, Guo H, Nemeth G, Harsanyi J, Thase ME. Cariprazine Augmentation to Antidepressant Therapy in Major Depressive Disorder: Results of a Randomized, Double-Blind, Placebo-Controlled Trial. Psychopharmacol Bull. 2018 Jun 20;48(4):62-80.
Results Reference
derived
Learn more about this trial
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)
We'll reach out to this number within 24 hrs