Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
12/01/2015
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

Prof A H Schene

ORCID ID

Contact details

Academic Medical Centre
Program for Mood Disorders
Department of Psychiatry
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+ 31 (0)20 566 2088
A.H.Schene@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR193

Study information

Scientific title

Dose Escalation Legitimate? Pharmacology and Imaging studies in depression

Acronym

DELPHI-trial and DELPHI-SPECT

Study hypothesis

Dose-escalation of paroxetine (up to 50 mg/day) does not increase efficacy of treatment of major depressive disorder in patients who did not respond to a six week trial of paroxetine in a standard dose (20 mg/day).

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, double-blinded, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Depression, major depressive disorder

Intervention

After six weeks of open treatment with a standard dose of paroxetine (20 mg/day) the patients who have not responded (less than 50% decrease in baseline HDRS-17) will be randomised to receive either a true or a placebo increase (by capsules) in addition to the standard dose.

Intervention type

Drug

Phase

Not Applicable

Drug names

Paroxetine

Primary outcome measures

1. Response and remission rates (decrease of greater than or equal to 50% in HDRS-17 and HDRS-17 less than or equal to 7 respectively)
2. Total and specific (due to side-effects or inefficacy) drop-out

Secondary outcome measures

1. Occurrence of side-effects (physical and sexual)
2. Subjective well-being and 36-item Medical Outcome Study Short-Form Health Survey (MOS-SF-36) quality of life
3. Direct and indirect costs (TiC-P)

Overall trial start date

01/11/2003

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) (determined by Structured Interview for DSM-IV [SCID-I])
2. 17-item Hamilton Depression Rating Scale (HDRS-17) greater than 18
3. Age 18 to 70 years
4. Maximum of one previous treatment-trial with an antidepressant (of adequate duration [6 weeks] and dosage [maximum recommended dose]) for the current MDD episode

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Bipolar disorder, psychosis or cognitive impairment (dementia or low intelligence quotient [IQ])
2. Use of psychoactive medication (except low doses of benzodiazepines)
3. Previous adequate trial with paroxetine with insufficient response for the current episode
4. Primary alcohol or drugs abuse
5. MDD secondary to co-morbid anxiety or somatophorm disorder
6. Somatic illnesses, e.g. untreated thyroid or other endocrine illnesses, systemic illnesses
7. Pregnancy or wish to become pregnant
8. Severe and acute suicidality
9. Insufficient knowledge of Dutch to fill in questionnaires

Recruitment start date

01/11/2003

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

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

1. 2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/18830236
2. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21903032
3. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25544738

Publication citations

  1. Results

    Ruhé HG, Booij J, v Weert HC, Reitsma JB, Franssen EJ, Fransen EJ, Michel MC, Schene AH, Evidence why paroxetine dose escalation is not effective in major depressive disorder: a randomized controlled trial with assessment of serotonin transporter occupancy., Neuropsychopharmacology, 2009, 34, 4, 999-1010, doi: 10.1038/npp.2008.148.

  2. Results

    Ruhé HG, Booij J, Veltman DJ, Michel MC, Schene AH, Successful pharmacologic treatment of major depressive disorder attenuates amygdala activation to negative facial expressions: a functional magnetic resonance imaging study., J Clin Psychiatry, 2012, 73, 4, 451-459, doi: 10.4088/JCP.10m06584.

  3. Results

    Ruhé HG, Khoenkhoen SJ, Ottenhof KW, Koeter MW, Mocking RJ, Schene AH, Longitudinal effects of the SSRI paroxetine on salivary cortisol in Major Depressive Disorder, Psychoneuroendocrinology, 2014 , 52C, 261-271, doi: 10.1016/j.psyneuen.2014.10.024.

Additional files

Editorial Notes