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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01111552




Registration number
NCT01111552
Ethics application status
Date submitted
22/04/2010
Date registered
27/04/2010

Titles & IDs
Public title
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
Scientific title
A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder
Secondary ID [1] 0 0
2010-018858-12
Secondary ID [2] 0 0
31-08-256
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder (MDD) 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Escitalopram
Treatment: Drugs - Aripiprazole
Treatment: Drugs - Placebo

Active comparator: Phase B: Single-blind Prospective Treatment Phase - Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the end of Week 1 based upon tolerability profile, plus one matching placebo capsule, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.

Active comparator: Phase B+: Single-blind Phase B Responders - Participants with response at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day) taken during the final week of Phase B plus one matching placebo capsule, for an additional 6 weeks, in Phase B+.

Active comparator: Phase C: Escitalopram Monotherapy - Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B plus one matching placebo capsule for 6 weeks, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.

Active comparator: Phase C: Aripiprazole Monotherapy - Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily plus one matching placebo capsule for 6 weeks, in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any week, based upon tolerability.

Active comparator: Phase C: Aripiprazole/Escitalopram Combination Therapy - Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally, once daily plus one matching placebo capsule for 6 weeks, in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.


Treatment: Drugs: Escitalopram
Escitalopram oral capsules.

Treatment: Drugs: Aripiprazole
Aripiprazole oral capsules.

Treatment: Drugs: Placebo
Study drug matching placebo capsule.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)
Timepoint [1] 0 0
Week 8 to Week 14
Secondary outcome [1] 0 0
Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at The End of Phase C (Week 14)
Timepoint [1] 0 0
Week 14
Secondary outcome [2] 0 0
Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)
Timepoint [2] 0 0
Week 8 to Week 14

Eligibility
Key inclusion criteria
* Participants with a current diagnosis of a major depressive episode. The current depressive episode must be = 8 weeks in duration
* Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period
* Participants with a 17-item Hamilton Depression Rating Scale (HAM-D17) total score = 18 at the Baseline Visit for the Prospective Treatment Phase.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Lack of prior treatment with an antidepressant during the current depressive episode
* Participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode.
* Participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode
* Participants with epilepsy or significant history of seizure disorders
* Participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder
* Participants who have received electroconvulsive therapy (ECT) in the last 10 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/09/2011
Sample size
Target
Accrual to date
Final
237
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
- Brisbane
Recruitment hospital [2] 0 0
- Everton Park
Recruitment hospital [3] 0 0
- Malvern
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Fremantle
Recruitment postcode(s) [1] 0 0
4000 - Brisbane
Recruitment postcode(s) [2] 0 0
4053 - Everton Park
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
6959 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Bourgas
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Lovech
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Novi Iskar
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Pleven
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Plovdiv
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Rousse
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Tsarev Brod
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Tserova Koria
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Varna
Country [23] 0 0
India
State/province [23] 0 0
Andhra Pradesh
Country [24] 0 0
India
State/province [24] 0 0
Karnataka
Country [25] 0 0
India
State/province [25] 0 0
Maharashtra
Country [26] 0 0
India
State/province [26] 0 0
Punjab
Country [27] 0 0
India
State/province [27] 0 0
Tamil Nadu
Country [28] 0 0
India
State/province [28] 0 0
Uttar Pradesh
Country [29] 0 0
Philippines
State/province [29] 0 0
NCR
Country [30] 0 0
Romania
State/province [30] 0 0
Bucuresti
Country [31] 0 0
Romania
State/province [31] 0 0
Craiova
Country [32] 0 0
Romania
State/province [32] 0 0
Iasi
Country [33] 0 0
Romania
State/province [33] 0 0
Targoviste
Country [34] 0 0
Romania
State/province [34] 0 0
Targu Mures
Country [35] 0 0
Slovakia
State/province [35] 0 0
Michalovce
Country [36] 0 0
Slovakia
State/province [36] 0 0
Rimavska Sobota
Country [37] 0 0
Slovakia
State/province [37] 0 0
Svidnik
Country [38] 0 0
Slovakia
State/province [38] 0 0
Trencin
Country [39] 0 0
Slovakia
State/province [39] 0 0
Zlate Moravce

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Otsuka Pharmaceutical Development & Commercialization, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Available to whom?
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinical-trials.otsuka.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01111552