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
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
-
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.
-
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.
-
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.