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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 ├ůsberg Depression Rating Scale (MADRS)

Secondary outcome:

MADRS

Hospital 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

Page last updated: August 23, 2015

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