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ID
Source
Brief title
Health condition
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
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in HRSD scores.
Secondary outcome
1. Change in CGI scores;
2. Response defined as > 50% reduction on HRSD compared to baseline;
3. Remission defined as an end score of < 7 on the HRSD.
Background summary
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.
Study objective
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.
Intervention
1. Venlafaxine (maximum dose 375 mg);
2. Imipramine (dose adjustment to adequate plasma levels of 200-300 µg/l).
P.O. Box 2040
W.W. Broek, van den
Rotterdam 3000 CA
The Netherlands
w.w.vandenbroek@erasmusmc.nl
P.O. Box 2040
W.W. Broek, van den
Rotterdam 3000 CA
The Netherlands
w.w.vandenbroek@erasmusmc.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL563 |
| NTR-old | NTR619 |
| Other | : N/A |
| ISRCTN | ISRCTN73221288 |