Safety Study of ORG 34517 for Major Depression With Psychotic Features

Weill Cornell Medicine (WCM)

Status and phase

Completed

Phase 2

Conditions

Psychotic Disorders

Major Depressive Disorder

Treatments

Drug: ORG 34517

Study type

Interventional

Funder types

Other

Identifiers

NCT00226278

28130

Details and patient eligibility

About

Patients suffering from Major Depressive Disorder with Psychotic features who have received no changes in their medications in the previous two weeks will receive "usual" treatment of antidepressants, antipsychotics and/or mood stabilizers and adjunct therapy using ORG34517. The patient will be hospitalized for up to two weeks to monitor their medications and progress and will return to the site for periodic assessments.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

provide voluntary written informed consent for trial participation after the scope and nature of the investigation have been explained to them, and before starting any trial related activities
be able to speak, read, understand, respond to questions and follow instructions in English
have a DSM-IV severe depressive episode with psychotic features, as diagnosed by the MINI for single or recurrent episodes
have a score on PANSS item "Delusions" AND/OR "Hallucinatory behavior" of at least 4 at screening and baseline
have a PANSS Positive Scale score of at least 16 at screening and baseline
have a total score of at least 18 on teh HAMD 17 item scale at Screening and Baseline
be on a stable dose of usual treatment which has to consist of an anti-depressant, an antipsychotic, a mood stabilizer or any combination of these three drug classes
be 18 up to and including 70 years of age at Screening
must be willing to be hospitalized for at least 11 days from Screening onwards.

Exclusion criteria

have any other psychiatric diagnosis except MDD
have a lifetime psychiatric diagnosis of Bipolar Disorder I, schizophrenia or schizoaffective disorders
are at significant risk of committing suicide
are currently treated with carbamazepine or valproate
are currently treated with midazolam
have been treated with electroconvulsive therapy in the current episode
are currently treated with more than one antidepressant
are currently treated with more than one antipsychotic
are currently treated with more than one mood stabilizer
have usual treatment started or discontinued in the two weeks before randomization
have a usual treatment dose change within the week prior to randomization
have any clinically unstable or uncontrollable renal, hepatic, respiratory, haematological, cardiovascular or cerebrovascular disease that would put the patient at risk of safety or bias assessment efficacy
have known hypersensitivity reactions to glucocorticoid antagonists
have any clinically significant abnormal laboratory data
have any untreated or uncompensated clinically significant endocrine disorder
have a diagnosis or alcohol and/or drug dependence
have a confirmed positive result on the drug screening test for any illicit drug except cannabis
are using hormone replacement therapy at Screening
require concomitant treatment with corticosteroids
are subjects diagnosed with Cushing disease
are women of childbearing potential without adequate contraception
are women with a positive pregnancy test at screening or baseline or are breastfeeding mothers
are male subjects with current diagnosis of prostrate hypertrophia or past history of symptoms of prostrate hypertrophia.