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
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 |
|---|---|
| A.H.Schene@amc.uva.nl |
Study information
| Study design | Multicentre, randomised, double-blinded, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Dose Escalation Legitimate? Pharmacology and Imaging studies in depression |
| Study acronym | DELPHI-trial and DELPHI-SPECT |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Paroxetine |
| Primary outcome measure | 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 study start date | 01/11/2003 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2003 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
University/education
University/education
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
