Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000571471
Ethics application status
Approved
Date submitted
2/11/2007
Date registered
6/11/2007
Date last updated
20/02/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study - Ziprasidone used as an Adjunctive Therapy in patients with Major Depressive Disorder: Impact on Symptoms and Functional Disability
Scientific title
A Pilot Study - Ziprasidone used as an Adjunctive Therapy in patients with Major Depressive Disorder: Impact on Symptoms and Functional Disability
Universal Trial Number (UTN)
Trial acronym
Ziprasidone in Major Depression
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 2522 0
Condition category
Condition code
Mental Health 2618 2618 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The starting dose of 20mg oral Ziprasidone hydrochloride daily, will be gradually increased up to the maximum daily dose of 80mg for 3 weeks. During this time, the daily dose will be increased or decreased as required, based on the subject’s tolerability. Once established, the subject will remain on this stable dose for the remaining 3 weeks of the study.
Intervention code [1] 2250 0
Treatment: Drugs
Comparator / control treatment
Uncontrolled; single group trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3528 0
A > 20% change in score on the Hamilton Depression Rating Scale (HAMD-17), from baseline to week 6.
Timepoint [1] 3528 0
At baseline, and at 2,4 and 6 weeks after intervention commencement.
Primary outcome [2] 3529 0
A reduction in the Clinical Global Impression Scale (CGI) score by at least 1 point, from baseline to week 6.
Timepoint [2] 3529 0
At baseline, and at 2,4 and 6 weeks after intervention commencement.
Secondary outcome [1] 5911 0
N/A
Timepoint [1] 5911 0
N/A

Eligibility
Key inclusion criteria
1. Patients with a diagnosis of Major Depressive Disorder (MDD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria
2. Aged 18 to 55 years old
3. A history during the current depressive episode of an incomplete or partial response to a trial of a selective serotonin reuptake inhibitors antidepressant (SSRIs), or a noradrenergic and specific serotonergic antidepressant (NASSA), at an adequate dose for a minimum of 6 weeks.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy
2. Lactation
3. Severe or unstable medical condition
5. Co-morbid diagnosis of any primary psychotic disorder or Personality Disorder
6. Co-morbid diagnosis of alcohol/substance abuse
7. Unable to obtain written informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
15/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 318 0
3144

Funding & Sponsors
Funding source category [1] 2765 0
Commercial sector/Industry
Name [1] 2765 0
Pfizer Global Pharmaceuticals
Country [1] 2765 0
Australia
Primary sponsor type
Individual
Name
Dr Nitin Dharwadkar
Address
The Melbourne Clinic
12/140 Church St
Richmond
VIC
3121
Country
Australia
Secondary sponsor category [1] 2498 0
Other Collaborative groups
Name [1] 2498 0
Victorian Psychopharmacology Research Group
Address [1] 2498 0
290 Glenferrie Road
Malvern
VIC
3144
Country [1] 2498 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4686 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 4686 0
Cabrini Clinical Education and Research Institute
183 Wattletree Road
Malvern
3144
Ethics committee country [1] 4686 0
Australia
Date submitted for ethics approval [1] 4686 0
22/11/2007
Approval date [1] 4686 0
30/01/2008
Ethics approval number [1] 4686 0
02-10-12-07

Summary
Brief summary
This study is a 6-week, naturalistic open-label evaluation of the efficacy and tolerability of ziprasidone hydrochloride (20mg/day to 80mg/day), in combination with an antidepressant in the treatment of patients with major depressive disorder (MDD), and aims to assess the antidepressant effect of ziprasidone in conjunction with an antidepressant in treating patients who have shown an incomplete or partial response an antidepressant alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28158 0
Address 28158 0
Country 28158 0
Phone 28158 0
Fax 28158 0
Email 28158 0
Contact person for public queries
Name 11315 0
Dr Nitin Dharwadkar
Address 11315 0
The Melbourne Clinic
12/140 Church St
Richmond
VIC
3121
Country 11315 0
Australia
Phone 11315 0
+61 3 9090 7789
Fax 11315 0
+61 3 9886 7093
Email 11315 0
[email protected]
Contact person for scientific queries
Name 2243 0
Dr Nitin Dharwadkar
Address 2243 0
The Melbourne Clinic
12/140 Church St
Richmond
VIC
3121
Country 2243 0
Australia
Phone 2243 0
+61 3 9090 7789
Fax 2243 0
+61 3 9886 7093
Email 2243 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.