Major Depressive Disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The inclusion criteria were as follows: 1) Those aged 18 or over with MDD or anxiety disorder complication of MDD (by DSM-IV-TR). 2) Those treated with stable doses of paroxetine IR for at least 24 weeks presenting with stable symptoms, or those newly treated with paroxetine CR. 3) Gender and frequencies of past depression episodes do not matter.
Exclusion criteria
Exclusion criteria: The exclusion criteria were as follows: 1) Those with convulsive disorders such as schizophrenia and epilepsia or their previous history. 2) Those with depression or depressive state caused by organic brain damages. 3) Those with severe disorders in liver, kidney, blood or circulation. 4) Those with malignancy or its previous history. 5) Those pregnant, nursing, or who may become pregnant. 6) Those with heavy suicidal tendency, previous history of suicidal ideation, or suicide attempt. 7) Those with personality disorder, mental retardation or intractable depression at a physician's discretion. 8) Those with substance dependence or drug abuse (excluding disorders related to nicotine). 9) Those who have had modified doses of concomitant drugs (excluding paroxetine CR) during the last 8 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of efficacy are the frequencies of adverse drug reactions (ADRs) as well as the total scores of HSDS/HSAS (Himorogi Self-rating Depression/Anxiety Scale) evaluated at the time of medication change from paroxetine IR to paroxetine CR (0W), during the 4th week (4W), and during the 8th week (8W) of the trial. | — |
Countries
Japan
Contacts
Himorogi Psychiatric Institute Head Director