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Trial record 39 of 64 for:    brexpiprazole

Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

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ClinicalTrials.gov Identifier: NCT01987960
Recruitment Status : Terminated (The study was terminated due to challenges with patient eligibility; the decision to terminate was not based on any safety concerns)
First Posted : November 20, 2013
Results First Posted : March 13, 2017
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Post-traumatic Stress Disorder
PTSD
Interventions Drug: Placebo
Drug: Brexpiprazole
Enrollment 417
Recruitment Details 417 patients were enrolled to the study and 413 patients received open-label treatment with a commercially available treatment for PTSD (PAR/SER) in Period 1. Only 40 patients were randomized to Period 2, the randomized period, before the study was terminated; 190 patients entered Period 3. Data are only reported for the randomized period.
Pre-assignment Details  
Arm/Group Title Period 1 Placebo and PAR/SER Period 2 Placebo and PAR/SER (Randomized Period) Period 2 Brexpiprazole and PAR/SER (Randomized Period) Period 3 Placebo and PAR/SER
Hide Arm/Group Description

Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER).

Placebo: Once daily, tablets, orally

Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.

Placebo: Once daily, tablets, orally

Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period

Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally

Continuation of treatment with placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) from Period 1.

Placebo: Once daily, tablets, orally

Period Title: Period 1
Started 417 0 0 0
Completed 231 0 0 0
Not Completed 186 0 0 0
Reason Not Completed
Adverse Event             24             0             0             0
Lack of Efficacy             4             0             0             0
Non-compliance with IMP             6             0             0             0
Protocol Violation             12             0             0             0
Withdrawal by Subject             21             0             0             0
Lost to Follow-up             40             0             0             0
administrative or other reason             75             0             0             0
Withdrawal of consent before treatment             4             0             0             0
Period Title: Period 2
Started 0 17 23 0
Completed 0 12 14 0
Not Completed 0 5 9 0
Reason Not Completed
Adverse Event             0             0             1             0
Withdrawal by Subject             0             0             1             0
Administrative or other reason             0             5             7             0
Period Title: Period 3
Started 0 0 0 190
Completed 0 0 0 119
Not Completed 0 0 0 71
Reason Not Completed
Adverse Event             0             0             0             7
Non-compliance with IMP             0             0             0             1
Protocol Violation             0             0             0             6
Withdrawal by Subject             0             0             0             9
Lost to Follow-up             0             0             0             5
Administrative or other reason             0             0             0             43
Arm/Group Title Period 2 Placebo and PAR/SER (Randomized Period) Period 2 Brexpiprazole and PAR/SER (Randomized Period) Total
Hide Arm/Group Description

Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.

Placebo: Once daily, tablets, orally

Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.

Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally

Total of all reporting groups
Overall Number of Baseline Participants 17 23 40
Hide Baseline Analysis Population Description
The all-patients-treated set (APTS) comprises all randomized patients who took at least one dose of brexpiprazole or placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 23 participants 40 participants
42.9  (11.8) 47.6  (10.4) 45.6  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 23 participants 40 participants
Female
10
  58.8%
11
  47.8%
21
  52.5%
Male
7
  41.2%
12
  52.2%
19
  47.5%
1.Primary Outcome
Title PTSD Symptoms Using CAPS-2 Total Score
Hide Description Clinician-Administered PTSD Scale Part 2 (CAPS-2): 17 items in criteria B, C and D (Corresponding to CAPS-2) will be administered to provide a total score. They are rated on a 5 point scale for frequency from 0 (never or none) to 4 (daily or almost every day), and intensity from 0 (none) to 4 (extreme). The sum of the 17 items gives a toal score ranging from 0 to 136, with a higher score indicating greater symptom severity.
Time Frame Period 2: Baseline to Week 12 (of randomized period)
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done
Arm/Group Title Period 2 Absolute Mean at Baseline; Placebo and PAR/SER Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER Period 2 Absolute Mean at Week 12; Placebo and PAR/SER Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER
Hide Arm/Group Description:

Period 2 absolute mean value at Baseline; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.

Placebo: Once daily, tablets, orally

Period 2 absolute mean value at Baseline; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.

Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally

Period 2 absolute mean value at Week 12; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.

Placebo: Once daily, tablets, orally

Absolute values at Week 12 in Period 2 (Study Week 24)

Period 2 absolute mean value at Week 12; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.

Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally

Absolute values at Week 12 in Period 2 (Study Week 24)

Overall Number of Participants Analyzed 17 23 15 17
Mean (Standard Deviation)
Unit of Measure: Score
82.82  (12.94) 83.43  (13.12) 69.67  (20.26) 69.18  (18.17)
2.Secondary Outcome
Title Global Clinical Impression Severity of Illness (CGI-S) Score
Hide Description Clinical Global Impression - Severity of Illness (CGI-S) The CGI-S provides the clinician’s impression of the patient’s current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient’s current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
Time Frame Period 2: Baseline to Week 12 (of randomized period)
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done.
Arm/Group Title Period 2 Absolute Mean at Baseline; Placebo and PAR/SER Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER Period 2 Absolute Mean at Week 12; Placebo and PAR/SER Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER
Hide Arm/Group Description:

Period 2 absolute mean value at Baseline; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.

Placebo: Once daily, tablets, orally

Period 2 absolute mean value at Baseline; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.

Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally

Period 2 absolute mean value at Week 12; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) Placebo: Once daily, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24); randomized period.

Period 2 absolute mean value at Week 12; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.

Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day. Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24).

Overall Number of Participants Analyzed 17 23 15 17
Mean (Standard Deviation)
Unit of Measure: Score
4.24  (0.83) 4.54  (0.73) 3.73  (1.10) 3.94  (0.83)
Time Frame Period 2: Baseline to Week 16 (randomized period)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brexpiprazole + PAR/SER (Randomized Period) Placebo + PAR/SER (Randomized Period)
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Brexpiprazole + PAR/SER (Randomized Period) Placebo + PAR/SER (Randomized Period)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brexpiprazole + PAR/SER (Randomized Period) Placebo + PAR/SER (Randomized Period)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brexpiprazole + PAR/SER (Randomized Period) Placebo + PAR/SER (Randomized Period)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/23 (13.04%)   8/17 (47.06%) 
Eye disorders     
Conjunctivitis  1  0/23 (0.00%)  1/17 (5.88%) 
Infections and infestations     
Gastroenteritis  1  0/23 (0.00%)  1/17 (5.88%) 
Pharyngitis  1  0/23 (0.00%)  1/17 (5.88%) 
Upper respiratory tract infection  1  0/23 (0.00%)  1/17 (5.88%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  2/23 (8.70%)  1/17 (5.88%) 
Tendon rupture  1  0/23 (0.00%)  1/17 (5.88%) 
Metabolism and nutrition disorders     
Hypercholesterolaemia  1  0/23 (0.00%)  1/17 (5.88%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/23 (4.35%)  1/17 (5.88%) 
Nervous system disorders     
Disturbance in attention  1  0/23 (0.00%)  1/17 (5.88%) 
Reproductive system and breast disorders     
Galactorrhoea  1  0/23 (0.00%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  0/23 (0.00%)  1/17 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
As the study was terminated limited efficacy and safety data were collected from the randomized patients. The data are descriptive and the primary and key secondary efficacy analyses were not done.
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: H. Lundbeck
Organization: A/S
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01987960     History of Changes
Other Study ID Numbers: 14865A
2012-004982-41 ( EudraCT Number )
First Submitted: November 13, 2013
First Posted: November 20, 2013
Results First Submitted: October 28, 2016
Results First Posted: March 13, 2017
Last Update Posted: March 13, 2017