Phase 2
Completed N=490
Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder
Source: ClinicalTrials.gov NCT00807248 ↗Enrolled (actual)
490
Serious AEs
0.2%
Results posted
Aug 2011
Primary outcomePrimary: Montgomery and Åsberg Depression Rating Scale (MADRS) — -13.4; -19.0; -18.5; -19.4 Scores on a scale — p=0.6405
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery and Åsberg Depression Rating Scale (MADRS) |
-13.4; -19.0; -18.5; -19.4 | 0.6405 |
| SECONDARY MADRS |
-13.4; -19.0; -18.5; -19.4 | <0.0001 sig |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) |
-9.7; -14.7; -14.1; -15.0 | <0.0001 sig |
| SECONDARY Insomnia Severity Index (ISI) |
-6.9; -10.0; -9.6; -10.6 | <0.0001 sig |
| SECONDARY Sheehan Disability Scale (SDS): Family Subscale |
-2.8; -4.0; -3.9; -4.1 | <0.0001 sig |
| SECONDARY SDS: Work Subscale |
-2.7; -3.8; -3.8; -4.0 | 0.0007 sig |
| SECONDARY SDS: Social Subscale |
-2.7; -3.9; -3.8; -4.1 | 0.0002 sig |
| SECONDARY Clinical Global Impression - Severity of Illness (CGI-S) |
-1.04; -1.65; -1.58; -1.76 | <0.0001 sig |
| SECONDARY Clinical Global Impression - Global Improvement (CGI-I) |
2.97; 2.21; 2.35; 2.26 | <0.0001 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00807248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.