Major Depressive Disorder Clinical Trial
Official title:
Double-Blind, Placebo Controlled Trial of Metyrapone as Augmenting Agent in the Treatment of Major Depression
The purpose of this study is to test whether metyrapone is an effective and safe augmenting agent in the treatment of major depression.
Status | Completed |
Enrollment | 63 |
Est. completion date | July 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of major depressive disorder; single or recurrent according to DSM-IV criteria (296.2 or 296.3) - A minimum baseline Hamilton score of 18 points on the Hamilton Rating Scale for Depression (HamD; 21-item version) - Age from 18 to 75 years - A drug free period of at least 5 days from antidepressants, antipsychotics, mood stabilizers and all other medications except for mild antihypertensive agents - A negative urinary drug screening diagnosis Exclusion Criteria: - A current DSM-IV diagnosis for other axis I psychiatric disorders - Serious medical conditions, especially those associated with adrenal insufficiency - Pregnancy, nursing or refusal to use a reliable method of birth control in women. Participants were randomly assigned to a study group if they met these criteria. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Dept. of Psychiatry and Psychotherapy, UKE | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Jahn H, Schick M, Kiefer F, Kellner M, Yassouridis A, Wiedemann K. Metyrapone as additive treatment in major depression: a double-blind and placebo-controlled trial. Arch Gen Psychiatry. 2004 Dec;61(12):1235-44. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Two psychometric criteria defined by the number of responders and time to onset-of-action. The number of responders was considered twice after 3 and 5 weeks by defining the treatment response as a 30% and 50% reduction | |||
Primary | the course of concentrations of ACTH, cortisol, 11-deoxycortisol and DHEA. | |||
Secondary | Other psychometric scores, demographic parameters and side effects were considered as secondary variables. |
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