Dose Escalation Legitimate? Pharmacology and Imaging studies in depression

ISRCTN ISRCTN44111488
DOI https://doi.org/10.1186/ISRCTN44111488
Secondary identifying numbers NTR193
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
12/01/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof A H Schene
Scientific

Academic Medical Centre
Program for Mood Disorders
Department of Psychiatry
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone + 31 (0)20 566 2088
Email A.H.Schene@amc.uva.nl

Study information

Study designMulticentre, randomised, double-blinded, placebo controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleDose Escalation Legitimate? Pharmacology and Imaging studies in depression
Study acronymDELPHI-trial and DELPHI-SPECT
Study objectivesDose-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(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedDepression, major depressive disorder
InterventionAfter 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Paroxetine
Primary outcome measure1. 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 measures1. 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 study start date01/11/2003
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants500
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2003
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
University/education

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2009 Yes No
Results article results 01/04/2012 Yes No
Results article results 01/02/2015 Yes No