1. Imipramine and Venlafaxine are comparable in efficacy in inpatients with a major depression; 2. Imipramine and Venlafaxine are comparable in tolerability; 3. Patients with a Venlafaxine plasma level < 195 µg/L show comparable antidepressant…
ID
Bron
Verkorte titel
Aandoening
This is a double blind, randomized study with a washout period, comparing 2 treatments strategies.
Study duration is 1 week washout period, 7 weeks acute treatment and continuation treatment of responders during 4 months.
One condition is with imipramine with adequate plasma levels the other is venlafaxine with optimal dosage
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change in HRSD scores.
Achtergrond van het onderzoek
TITLE:
Pharmacological treatment of Depression: Phase I Venlafaxine versus Imipramine
OBJECTIVES:
Primary:
1. To compare in inpatients with a depression the antidepressant efficacy at seven weeks of two treatment arms: (1) 7 weeks Venlafaxine (maximum dose 375 mg); (2) 7 weeks Imipramine (dose adjustment to adequate plasma levels of 200-300 mug/day).
Secondary:
1. To compare in patients with a depression the tolerability of Venlafaxine and Imipramine;
2. Evaluate efficacy and tolerability during continuation of 4 months of treatment in the responders;
3. Measure plasma level of Venlafaxine:
Patients with Venlafaxine plasma levels under 195 µg/L (not a therapeutical range) show lesser improvement in HRSD/ CGI scores.
TYPE OF PATIENTS:
Inpatients of the Erasmus MC with a severe major depression.
NUMBER OF PATIENTS:
138.
TRIAL DESIGN:
A double blind, randomized singlecentre study with a washout period, comparing 2 treatment strategies.
TRIAL TREATMENTS:
1. Venlafaxine (maximum dose 375 mg);
2. Imipramine (dose adjustment to adequate plasma levels of 200-300 µg/l).
DURATION OF TREATMENT:
One week washout and 7 weeks acute treatment with Venlafaxine or Imipramine. Total of 8 weeks;
FOLLOW-UP:
Continuation treatment of responders during 4 months.
PRIMARY ENDPOINTS:
Proportion of responders.
Change in:
1. HRSD scores;
2. CGI scores;
3. Time to response;
4. Adverse effects.
Doel van het onderzoek
1. Imipramine and Venlafaxine are comparable in efficacy in inpatients with a major depression;
2. Imipramine and Venlafaxine are comparable in tolerability;
3. Patients with a Venlafaxine plasma level < 195 µg/L show comparable antidepressant efficacy as patients with a Venlafaxine plasma level > 195 µg/L;
4. Imipramine and Venlafaxine are comparable in efficacy during 4 months follow-up;
5. Imipramine and Venlafaxine are comparable in tolerability during 4 months follow-up.
Onderzoeksproduct en/of interventie
1. Venlafaxine (maximum dose 375 mg);
2. Imipramine (dose adjustment to adequate plasma levels of 200-300 µg/l).
Publiek
P.O. Box 2040
W.W. Broek, van den
Rotterdam 3000 CA
The Netherlands
w.w.vandenbroek@erasmusmc.nl
Wetenschappelijk
P.O. Box 2040
W.W. Broek, van den
Rotterdam 3000 CA
The Netherlands
w.w.vandenbroek@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
For inclusion in the trial, patients must fulfill all of the following criteria:
1. Age 18-65;
2. Major depressive disorder, single or recurrent episode (DSM-IV);
3. HRSD (17 item) >= 14;
4. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Any of the following is regarded as a criterion for exclusion from the trial:
1. Patients whom are incapable to understand the information and to give informed consent. And patients whom are unable to read or write;
2. Major depression with psychotic features (separate study);
3. Bipolar I or II disorder;
4. Schizophrenia or other primary psychotic disorder;
5. Treatment of current episode with adequate trial of Imipramine or Venlafaxine;
6. Drug/ alcohol dependence last 3 months;
7. Mental retardation (IQ < 80);
8. Women: pregnancy or possibility for pregnancy and no adequate contraceptive measures. Breastfeeding;
9. Serious medical illness affecting CNS, e.g.: M. Parkinson, SLE, brain tumor, CVA;
10. Relevant medical illness as contra-indications for the use of study medication (Venlafaxine and Imipramine), such as recent myocardial infarction and severe liver or kidney failure;
11. Medication affecting CNS, e.g.: antidepressants and/or antipsychotics other than study medication, steroids (prednison), mood stabilisers, benzodiazepines (if not being tapered): > 3 mg lorazepam (or equivalent: see appendix Moleman P. 1998. Praktische psychofarmacologie. Derde druk. Bohn Stafleu Van Loghum page 19);
12. Direct ECT indication (e.g. very severely suicidal or refusal of food and drinking resulting in life threatening situation);
13. Contra-indications for Lithium (Moleman, 1998):
a. Kidney failure;
b. Acute myocard infarct;
c. Myasthenia gravis;
d. Breastfeeding.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL563 |
| NTR-old | NTR619 |
| Ander register | : N/A |
| ISRCTN | ISRCTN73221288 |