Condition category
Nervous System Diseases
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
04/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms E Driessen, MSc

ORCID ID

Contact details

Klaprozenweg 111
Amsterdam
1033 NN
Netherlands
+31 (0)20 590 5126
ellen.driessen@mentrum.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Praten & Pillen V

Study hypothesis

A randomised clinical trial comparing the efficacy, efficiency and applicability of short-term cognitive behavioural therapy and short-term psychoanalytical supportive psychotherapy in the treatment of depressive disorders.

Ethics approval

Approval received from the Dutch council of medical-ethic boards for mental health institutes (Stichting Medisch-Etische Toetsingscommissie Instellingen Geestelijke Gezondheidszorg [METiGG]) on the 12th May 2006 (ref: 5236).

Study design

Randomised, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Depressive disorders

Intervention

1. Mild to moderate depression (HDRS score 14 to 24):
Short-term Cognitive Behavioral Therapy or Short-term Psychoanalytical Supportive Psychotherapy, 16 sessions of 45 minutes, during 22 weeks.
2. Severe depressive symptoms (HDRS score more than 24):
Combination treatment: psychotherapy as mentioned above in combination with antidepressants.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Depressive complaints according to patient, therapist and independent rater at week 5, 10, 22 and 52.

Secondary outcome measures

1. Quality of life
2. Predictors of treatment outcome at week 22 and 52

Overall trial start date

01/04/2006

Overall trial end date

01/07/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Main diagnosis of:
a. Major Depressive Episode
b. Major Depressive Disorder
c. Depressive Disorder not otherwise specified according to Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria
2. Hamilton Depression Rating Scale (HDRS) score more than 14
3. Age 18 to 65
4. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

300

Participant exclusion criteria

1. Bipolar Disorder
2. Depressive disorder with psychotic features
3. Suicide risk
4. Loss of impulse-control
5. Use of non-trial anti-depressants
6. Use of anti-psychotics or mood stabilisers
7. Substance abuse
8. Language problems
9. Contact with same Mentrum location within last six months

Recruitment start date

01/04/2006

Recruitment end date

01/07/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Klaprozenweg 111
Amsterdam
1033 NN
Netherlands

Sponsor information

Organisation

Mentrum Mental Health Care Amsterdam (The Netherlands)

Sponsor details

P.O. Box 75848
Amsterdam
1070 AV
Netherlands

Sponsor type

Research organisation

Website

http://www.mentrum.nl/

Funders

Funder type

Industry

Funder name

Wyeth Pharmaceuticals (The Netherlands) - unrestricted grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24030613

Publication citations

  1. Results

    Driessen E, Van HL, Don FJ, Peen J, Kool S, Westra D, Hendriksen M, Schoevers RA, Cuijpers P, Twisk JW, Dekker JJ, The efficacy of cognitive-behavioral therapy and psychodynamic therapy in the outpatient treatment of major depression: a randomized clinical trial., Am J Psychiatry, 2013, 170, 9, 1041-1050, doi: 10.1176/appi.ajp.2013.12070899.

Additional files

Editorial Notes