Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000564055
Ethics application status
Approved
Date submitted
9/07/2010
Date registered
13/07/2010
Date last updated
13/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Patterns of treatment resistance and switching strategies in unipolar affective disorder
Scientific title
In patients with unipolar affective disorder who have failed to respond to an adequate trial of an antidepressant, is a switching strategy (from Citalopram to Despiramine or from Desipramine to Citalopram) more effective than a non-switching strategy in terms of response and remission rates?
Secondary ID [1] 252185 0
NIL
Universal Trial Number (UTN)
Trial acronym
TRD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment Resistant Depression 257722 0
Condition category
Condition code
Mental Health 257892 257892 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
patients not responding to one or more previous antidepressant treatment are randomly allocated to:
CITALOPRAM (CITA) 40-60 mg oral tablet once daily for 4 weeks vs DESIPRAMINE (DESI) 150-200 mg oral tablet twice daily for 4 weeks trials.
The non-responder patients after 4 weeks will be immediately divided in 4 arms with no wash out including
- 2 arms for continuation of the same antidepressant (AD) ('CITA' - 'CITA' and
'DESI' - 'DESI') at the same dose for 4 weeks.
- 2 arms for swiching from 'CITA' to 'DESI' and 'DESI' to 'CITA' for 4 weeks.

Flexible doses are allowed according to tolerance and efficacy:

- DESI: In some cases the maximum tolerated dose can be less than 200 mg, but must be at least 150 mg.
- The period to reach 150 mg or 200 mg of DESI can be adapted in function of tolerability. The dose can be reached slowly (but no more than 1 month in total), but it is mandatory to have at least 2 weeks of minimal dose (more than 150 mg). This means that some patients will be treated for 5 or 6 weeks. The same flexibility can be applied to citalopram for which the minimal dose is 40 mg.
- For patients > 65 years, the maximum doses are 200 mg/day for DESI and 40 mg/day for CITA.

-The highest dose administered will be maintained until the end of the study whenever possible. However, at any time after visit 2, the investigator may reduce a patient's dose to improve tolerance.
Intervention code [1] 256776 0
Treatment: Drugs
Comparator / control treatment
Arm 1: CITA crossover to CITA same dose.
Arm 2: DESI crossover to DESI same dose.
Arm 3: CITA crossover to DESI 150-200 mg as tolerated.
Arm 4: DESI crossover to CITA 40-60 mg as tolerated.
Control group
Active

Outcomes
Primary outcome [1] 258757 0
Response defined as a reduction of 50% or more from baseline Hamilton Rating Scale for Depression (HDRS)
Timepoint [1] 258757 0
HDRS is administered every week from baseline to week 8
Secondary outcome [1] 264815 0
Remission defined as a reduction below 8 of the Hamilton Rating Scale for Depression (HDRS)
Timepoint [1] 264815 0
HDRS is administered every week from baseline to week 8

Eligibility
Key inclusion criteria
a. Failure to respond to an adequate trial of antidepressant except CITA and DESI
(special cases: Patients who are treated with fluoxetine can be included only after switching to a short term antidepressant for 4 weeks. Similarly, patients treated by Monoamine oxidase inhibitors (MAOI) can be included only after a switch to moclobemide for 4 weeks.

b. HDRS more 17 (non remission) at screening

c. Provide written informed consent.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Major depressive episode with psychotic features

b. Major depression of patient with bipolar affective disorder

c. Concomitant severe axis II disorders (Borderline, paranoid, histrionic, antisocial, schizoid, schizotypal)

d. Drug or alcohol dependence, as defined in Diagnostic and Statistical Manual of Mental Disorder-IV

e. Concomitant obsessive compulsive disorder, post traumatic stress disorder, Schizophrenia

f. Affective disorder associated to a serious general medical condition not stabilized.

g. Seizure disorder other than a single childhood febrile seizure

h. Acute suicidal risk requiring alternative treatment(s)

i. Myocardial infarction within 6 months prior to screening (visit 1).

j. Clinically significant hepatic or renal disease or any other disease that might compromise the study or be detrimental to the patient.

k. Uncontrolled hypertension. Patients whose hypertension is controlled with antihypertensive drugs will be allowed into the study

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)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment outside Australia
Country [1] 2755 0
Belgium
State/province [1] 2755 0

Funding & Sponsors
Funding source category [1] 257267 0
Other Collaborative groups
Name [1] 257267 0
Group for the Study of Resistant Depression
Country [1] 257267 0
Belgium
Primary sponsor type
Other Collaborative groups
Name
Group for the Study of Resistant Depression
Address
Rue des Trois Arbres 62
1180 Bruxelles
Country
Belgium
Secondary sponsor category [1] 256511 0
None
Name [1] 256511 0
Address [1] 256511 0
Country [1] 256511 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259289 0
Ethical Committee Erasme Hospital
Ethics committee address [1] 259289 0
Ethics committee country [1] 259289 0
Belgium
Date submitted for ethics approval [1] 259289 0
01/05/1999
Approval date [1] 259289 0
10/08/1999
Ethics approval number [1] 259289 0

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

Contacts
Principal investigator
Name 31378 0
Address 31378 0
Country 31378 0
Phone 31378 0
Fax 31378 0
Email 31378 0
Contact person for public queries
Name 14625 0
Daniel Souery
Address 14625 0
Psy Pluriel - Centre Europeen de Psychologie Medicale Rue des Trois Arbres 62 1180 Bruxelles
Country 14625 0
Belgium
Phone 14625 0
+32 2 331 5665
Fax 14625 0
Email 14625 0
[email protected]
Contact person for scientific queries
Name 5553 0
Daniel Souery
Address 5553 0
Psy Pluriel - Centre Europeen de Psychologie Medicale Rue des Trois Arbres 62 1180 Bruxelles
Country 5553 0
Belgium
Phone 5553 0
+32 2 331 5665
Fax 5553 0
Email 5553 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.