Pharmacological Treatment of Depression.

A double-blind study comparing Venlafaxine with imipramine in depressed patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22391

Enrollment

138

Registered

2006-03-08

Start date

2004-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

1. Venlafaxine (maximum dose 375 mg)

2. Imipramine (dose adjustment to adequate plasma levels of 200-300 µg/l).

Eligibility

Inclusion criteria

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

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 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 outcomes

Primary

Measure	Time frame
Change in HRSD scores.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactW.W. Broek, van den

Erasmus Medical Center, Department of Psychiatry, P.O. Box 2040

w.w.vandenbroek@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)