Pharmacogenetics to improve personalized antidepressant dosing in patients with severe depression; a randomized controlled trial using Tricyclic Antidepressants

Recruiting

Conditions: major depressive disorder
10027946

Registration Number: NL-OMON49004

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 250

Inclusion Criteria

Patients are in- and outpatients, having a primary diagnosis of severe major
depressive disorder (SCID-I diagnosis in agreement with DSM-5 criteria and a
Hamilton Rating Scale for Depression score * 19 (HRSD-17-item version), aged
18-65 years, who, according to their physician, are eligible for treatment with
a TCA (Nortriptyline (NOR), Clomipramine (CLOMI) or Imipramine (IMI)). The
choice of the specific TCA is at the discretion of the physician in attendance.

Exclusion Criteria

(1) Psychotic depression (2) Bipolar I or II disorder. (3) Schizophrenia or
other primary psychotic disorder.(4) Drug or alcohol dependence in the past 3
months. (5) Mental Retardation (IQ < 80). (6) For women: pregnancy or
possibility for pregnancy without adequate contraceptive measures. (7)
Breast-feeding. (8) Serious medical illness affecting the CNS, including but
not restricted to M Parkinson, SLE, brain tumour, CVA. (9) Relevant medical
illness as contra-indication for TCA use, such as recent myocardial infarction.
(10) Other drugs influencing the pharmacokinetics of the TCAs as based on a
list of interacting drugs. In case of psychotropic co-medication only a
benzodiazepine in a dose equivalent up to 4 mg lorazepam will be allowed.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure: Time to TCA plasma concentration in the therapeutic<br /><br>range (primary outcome measure). Blood for plasma concentration measurements<br /><br>will be taken in the morning, at 12 (+/-) 1 hours after the last evening dose.<br /><br>When a patient attains a plasma level within the therapeutic range at steady<br /><br>state, the primary endpoint has been reached (for nortriptyline 0.050.15 mg/l;<br /><br>for clomipramine: 0.150.30 mg/l (clomipramine plus desmethylclomipramine) and<br /><br>for imipramine 0.15-0.25 mg/l (imipramine plus desipramine).</p><br>

Secondary Outcome Measures