|- candidate number||1304|
|- NTR Number||NTR178|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||2-sep-2005|
|- Secondary IDs||OOG00-020 |
|- Public Title||Mild depression in primary care: do antidepressants add any effect to usual consultations?|
|- Scientific Title||Minor and mild-major depression in primary care: do antidepressants add any effects to usual consultations?|
|- hypothesis||Antidepressant medication does not add any effect to usual consultations by general practitioners in patients with minor and mild-major depression.|
|- Healt Condition(s) or Problem(s) studied||Depression|
|- Inclusion criteria||1. Aged 18 years or over; |
2. Having 3-6 out of 9 depressive symptoms for at least 2 weeks for most days of the week, including at least one of the core symptoms ‘sadness’ or ‘loss of pleasure’;
3. Impairment by depressive symptoms in social, occupational or other important areas of functioning. (minor depression=3-4 symptoms, mild-major depression=5-6 symptoms).
|- Exclusion criteria||1. Current intake of antidepressants or receiving psychological therapy;
2. Psychotic features;
3. Alcohol or drug addiction;
4. Loss of a loved one or significant other in the past six months;
5. Pregnancy or breastfeeding;
6. Inability to complete questionnaires because of language difficulties, illiteracy or cognitive decline;
7. Not having a telephone.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2002|
|- planned closingdate||1-mei-2005|
|- Target number of participants||181|
|- Interventions||Patients were randomly assigned to four sessions of counselling during 3 months with (n=85) or without paroxetine (n=96). Both treatments were carried out by the patient’s own GP. |
|- Primary outcome||1. Severity of Depressive by MADRS (Montgomery Åsberg Depression Rating Scale); |
2. Remission of depression by MADRS score<10.
|- Secondary outcome||1. Quality of Live (Short Form 36);|
2. Subjective deprssion (Beck Depr. Inventory);
3. Client Satisfaction Questionnaire;
4. Direct and indirect costs.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||PhD. Hein Hout, van|
|- CONTACT for SCIENTIFIC QUERIES||PhD. Hein Hout, van|
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|College voor Zorgverzekeringen|
|- Publications||BMC Med. 2007 Dec 7;5:36.|
|- Brief summary||Objective:|
To examine whether antidepressant medication adds any effect to usual consultations by the General Practitioner (GP) in adult patients with minor and mild-major depression.
A pragmatic patient-randomised equivalence trial with 12 months follow up.
59 GPs in The Netherlands recruited eligible patients.
181 contacting patients entered the study with minor or mild-major depression. Mean age was 46 years (SD 16.0) and 73% were female. Complete follow up on the primary outcomes was available for 131 patients (72%).
Patients were randomly assigned to on average 3 usual consultations during 3 months with (n=85) or without paroxetine (n=96). Both treatments were carried out by the patient’s own GP.
Main outcome measure:
Depression severity by the Montgomery Åsberg Depression Rating Scale and remission from depression at 6, 13, 26 and 52 weeks follow up. Secondary outcome measures were the Short Form 36, Beck Depression Inventory and Client Satisfaction Questionnaire.
The intention-to-treat analysis showed that paroxetine with counselling was equivalent (i.e. non-superior) to counselling alone at 6, 13 and 52 weeks, but not at 26 weeks. The power was too low to draw firm conclusions on the per-protocol analysis. Patients who received usual consultations were at least as satisfied with their treatment as patients receiving additional antidepressives. Non-inferiority of costs could be demonstrated for 76% of the cases.
Apparently, paroxetine does not add to the treatment effect of usual consultations by GPs in patients with minor and mild-major depression.
|- Main changes (audit trail)|
|- RECORD||26-aug-2005 - 9-jul-2008|