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Trial registered on ANZCTR


Registration number
ACTRN12608000479303
Ethics application status
Approved
Date submitted
8/09/2008
Date registered
29/09/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Depression in primary care:Interpersonal Counseling vs Selective Serotonin Reuptake Inhibitors(SSRI)
Scientific title
Interpersonal Counseling and Selective Serotonin Reuptake Inhibitors(SSRI) for the treatment of Major Depression in Primary Care
Secondary ID [1] 709 0
Nil
Universal Trial Number (UTN)
Trial acronym
DEPICS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depression 3645 0
Condition category
Condition code
Mental Health 3811 3811 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interpersonal counseling (IPC) .IPC is a short-term highly-structured psychological intervention, derived from Interpersonal Psychotherapy (IPT) and suitable for different medical contexts.IPC is a treatment of six thirty-minute sessions, with the initial session being longer (1 hour). IPC is self-dosing: the patient determines the length of treatment, many patients feel satisfied with fewer than six sessions.In our study IPC have been adapted to accommodate needs of patients with Major Depression. In the trial the recommended number of counseling sessions is six-eight thirty-minute sessions weekly. Therapist determines if there is need of one or two additional session (6+1 or 6 + 2).IPC is delivered by residents in psychiatry, or in clinical psychology .They attended a 3-days seminar on interpersonal theory’s foundations and IPC structure and techniques; clinical examples were also discussed. Subsequently, monthly supervisions were scheduled with an IPT supervisor in order to discuss cases and to warrant the intervention’s consistency. IPC sessions were videotaped, after a signed consent was obtained from the patient, and discussed during supervisions.
Patients with a HDRS score > or =13 at 2-months follow-up will receive a combined treatment including IPC and SSRI. In particular those in IPC arm begin the antidepressant therapy and will continue IPC for further 4-6 sessions.
Intervention code [1] 3360 0
Treatment: Other
Comparator / control treatment
SSRI Antidepressants.The study evaluates the antidepressant treatment for depression as it might be delivered routinely in a clinical practice. Thus two antidepressive agents – citalopram or sertraline are used– starting at 10-20 mg for citalopram and 25-50 mg for sertraline ,orally one daily, and eventually increasing until 60 mg or 200 mg, respectively, if depressive symptomatology does not improve (consultant psychiatrist clinical evaluation). The pharmacological treatment is continued for at least 4-6 months after the individual had responded as suggested by international guideline . Consultant psychiatrist chooses between the two treatment options based on his/her personal preference and informs Primary Care Physician by letter about the suggested pharmacological treatment. Moreover he/she provided psycho-education about antidepressants and theirs side effects. Two or three subsequent visits were planned every 2-3 weeks, lasting around 15 minutes in order to evaluate patients’ compliance, clinical response and initial side effects; a specific form was used to assess adverse events. Concerning SSRI the only one modification allowed is the switch from sertraline to citalopram and vice versa.Patients with a HDRS score > or =13 at 2-months follow-up will receive a combined treatment including IPC and SSRI. In particular those in SSRI arm begin a regular 6-sessions IPC.
Control group
Active

Outcomes
Primary outcome [1] 4709 0
The main outcome of the study is the remission of depressive symptomatology measured with Hamilton Depression Rating Scale (HDRS). The HDRS is the most widely used outcome measure in trials on depression . In detail we define remission a HDRS score less than 8.
Timepoint [1] 4709 0
HDRS will be administered at 2,6 months and 1 year
Secondary outcome [1] 7952 0
Secondary outcome measure is an improvement in subjective functioning measured with the Work and Social Adjustment Scale (WSAS) .It is a self-report 5-item scale used to measure functional impairment attributable to an identified problem or disorder. WSAS items investigates ability to work, home management, social leisure, private leisure, and relationships.
Timepoint [1] 7952 0
WSAS will be administered at 2,6 months and 1 year.
Secondary outcome [2] 7967 0
The recurrence of depressive symptoms at 12-months follow up visit.
Timepoint [2] 7967 0
Mini International Neuropsychiatry Interview (MINI) Plus will be readministered at 12-months follow up visit.
The instrument allows making a diagnosis according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) or International Statistical Classification of Diseases (ICD-10) criteria.

Eligibility
Key inclusion criteria
Adult patients (> or =18 years old)suffering from a Major Depression episode according to the DSM-IV criteria and having a score on Hamilton Depression Rating Scale (HDRS) > or =13 are eligible for the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are: more than one clinically significant depressive episode in personal history, moderate to high current suicide risk, current or past episodes of mania or hypomania, psychotic disorders, cognitive impairment (Mini Mental State Examination score =27), borderline or anti-social personality disorders, current substance abuse or dependence.
Furthermore, patients with poor knowledge of Italian language were excluded because they could not complete the scheduled assessments. Finally, pregnant or breastfeeding women and patients taking antidepressant drugs, mood stabilizers, antipsychotic agents or receving any kind of psychotherapy were excluded

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)
Allocation to treatment group is made by a research worker outside the clinical facilities where patients were enrolled assessed and treated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation derived from a computer random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1186 0
Italy
State/province [1] 1186 0
Bologna
Country [2] 1187 0
Italy
State/province [2] 1187 0
Pavia
Country [3] 1188 0
Italy
State/province [3] 1188 0
Modena
Country [4] 1189 0
Italy
State/province [4] 1189 0
Torino
Country [5] 1190 0
Italy
State/province [5] 1190 0
Perugia
Country [6] 1191 0
Italy
State/province [6] 1191 0
Foggia
Country [7] 1192 0
Italy
State/province [7] 1192 0
Bari
Country [8] 1193 0
Italy
State/province [8] 1193 0
Cagliari

Funding & Sponsors
Funding source category [1] 3831 0
Government body
Name [1] 3831 0
Education, University and Research Ministry
Address [1] 3831 0
Piazza Kennedy, 20
00144 Roma
Country [1] 3831 0
Italy
Primary sponsor type
Individual
Name
Prof.Domenico Berardi
Address
Institute of Psychiatry, Bologna University
viale Pepoli 5
40123 Bologna
Country
Italy
Secondary sponsor category [1] 3440 0
None
Name [1] 3440 0
Address [1] 3440 0
Country [1] 3440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5883 0
Comitato Etico dell'Azienda Ospedaliero-Universitaria di Bologna,Policlinico S.Orsola Malpighi
Ethics committee address [1] 5883 0
via Massarenti ,9
40138 Bologna
Ethics committee country [1] 5883 0
Italy
Date submitted for ethics approval [1] 5883 0
Approval date [1] 5883 0
05/07/2005
Ethics approval number [1] 5883 0
n.42/2005/U/Sper

Summary
Brief summary
The present study aims to compare a brief structured psychological intervention (IPC) with the use of antidepressants (SSRI) for the treatment of major depression in primary care.
The research will evaluate the efficacy of the IPC and antidepressant and it will also evaluate the efficacy of a combined therapy for non responder patients.
Finally it will be tested the hypothesis that this psychological approach can reduce relapses in one year compared with those related to the use of andepressants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28900 0
Address 28900 0
Country 28900 0
Phone 28900 0
Fax 28900 0
Email 28900 0
Contact person for public queries
Name 12057 0
Dr. Marco Menchetti
Address 12057 0
Institute of Psychiatry, Bologna University
viale Pepoli 5
40123 Bologna
Country 12057 0
Italy
Phone 12057 0
+39 051 524100
Fax 12057 0
+39 051 521030
Email 12057 0
marco.menchetti3@unibo.it
Contact person for scientific queries
Name 2985 0
Dr.Marco Menchetti
Address 2985 0
Institute of Psychiatry, Bologna University
viale Pepoli 5
40123 Bologna
Country 2985 0
Italy
Phone 2985 0
+39 051 524100
Fax 2985 0
+39 051 521030
Email 2985 0
marco.menchetti3@unibo.it

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary