Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder

Lundbeck

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Gaboxadol 5 mg; Drug: Gaboxadol placebo; Drug: Escitalopram 20 mg; Drug: Gaboxadol 10 mg; Drug: Escitalopram placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00807248

2008-000506-36 (Registry Identifier)

12213A

Details and patient eligibility

About

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

Full 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

Enrollment: 490 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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490 participants in 4 patient groups, including a placebo group

Escitalopram placebo and gaboxadol placebo

Placebo Comparator group

Treatment:

Drug: Gaboxadol placebo

Drug: Escitalopram placebo

Escitalopram 20 mg and gaboxadol placebo

Active Comparator group

Treatment:

Drug: Gaboxadol placebo

Drug: Escitalopram 20 mg

Escitalopram 20 mg and gaboxadol 5 mg

Experimental group

Treatment:

Drug: Gaboxadol 5 mg

Drug: Escitalopram 20 mg

Escitalopram 20 mg and gaboxadol 10 mg

Experimental group

Treatment:

Drug: Escitalopram 20 mg

Drug: Gaboxadol 10 mg