Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder
Information source: H. Lundbeck A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder
Intervention: Escitalopram placebo (Drug); Gaboxadol placebo (Drug); Escitalopram 20 mg (Drug); Gaboxadol 5 mg (Drug); Gaboxadol 10 mg (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: H. Lundbeck A/S Official(s) and/or principal investigator(s): Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com
Summary
To compare the efficacy of escitalopram fixed dose 20 mg/day in combination with fixed doses
of gaboxadol (5 and 10 mg/day) versus escitalopram fixed dose 20 mg/day after 8 weeks of
treatment in patients with Major Depressive Disorder
Clinical Details
Official title: Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study of Escitalopram in Combination With Two Fixed Doses of Gaboxadol Compared to Escitalopram in Major Depressive Disorder
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Montgomery and Åsberg Depression Rating Scale (MADRS)
Secondary outcome: MADRSHospital Anxiety and Depression Scale (HADS) Insomnia Severity Index (ISI) Sheehan Disability Scale (SDS): Family Subscale SDS: Work Subscale SDS: Social Subscale Clinical Global Impression - Severity of Illness (CGI-S) Clinical Global Impression - Global Improvement (CGI-I)
Detailed description:
Subjects participating in this study will be respectively randomised (1: 2:2: 2) to receive
either:
- placebo or
- escitalopram 20 mg/day or
- escitalopram 20 mg/day in combination with gaboxadol 5 mg/day or
- escitalopram 20 mg/day in combination with gaboxadol 10 mg/day
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Clinical Diagnosis of MDD according to DSM-IV-TR criteria:
- With reported duration of the current major depressive episode of at least 3 months
- With MADRS total score of at least 30
Exclusion Criteria:
The patient has 1 or more of the following:
- Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR
- Current or past history of: manic or hypomanic episode, schizophrenia, or any other
psychotic disorder, including major depression with psychotic features, mental
retardation, organic mental disorders, or mental disorders due to a general medical
condition as defined in the DSM-IV-TR
- Any substance disorder (except nicotine and caffeine) within the previous 6 months as
defined in the DSM-IV-TR
- Presence or history of a clinically significant neurological disorder (including
epilepsy)
- Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis,
Huntington disease, etc)
- Any Axis II disorder that might compromise the study
- Previous use of hallucinogenic drug
The patient has a significant risk of suicide according to the investigator's opinion, or
has a score >=5 on item 10 (suicidal thoughts) of the MADRS, or has made a suicide attempt
in the previous 12 months.
Locations and Contacts
AT001, Vienna 1090, Austria
RU019, Barnaul 656022, Russian Federation
RU018, Ekaterinburg 620905, Russian Federation
RU029, Izhevsk 426054, Russian Federation
RU020, Kemerovo 650036, Russian Federation
RU010, Krasnodar 350087, Russian Federation
RU012, Krasnodar 350007, Russian Federation
RU022, Kursk 30500, Russian Federation
RU001, Moscow 119992, Russian Federation
RU002, Moscow 119992, Russian Federation
RU003, Moscow 127083, Russian Federation
RU007, Moscow 144009, Russian Federation
RU015, Moscow 107076, Russian Federation
RU026, Moscow 115522, Russian Federation
RU028, Moscow 119992, Russian Federation
RU027, Saransk 430030, Russian Federation
RU013, Saratov 410060, Russian Federation
RU024, Saratov 410038, Russian Federation
RU021, Tomsk 634014, Russian Federation
RU016, Tver 170005, Russian Federation
RU014, Volgograd, Russian Federation
RU011, Yaroslavl 150003, Russian Federation
Additional Information
Starting date: November 2008
Last updated: December 13, 2012
|