Phase 4
Completed N=40
Brain GABA Levels and Treatment Response in Major Depressive Disorder
Source: ClinicalTrials.gov NCT00464711 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores — 16; 14 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to treatment with escitalopram in people with major depressive disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores |
16; 14 | — |
Eligibility Criteria
Inclusion Criteria
- Meet diagnostic criteria for current Major Depressive Disorder
- Men or women aged 18-65
- Medication-free for one week prior to the start of the study
- Agrees to use an effective form of contraception throughout the study
Exclusion Criteria
- Anyone who is suicidal
- Pregnant or breastfeeding women
- Anyone with a serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease
- Anyone with a history of seizure disorder or hypothyroidism
- Anyone with a history of psychiatric disorders including bipolar disorder, schizophrenia, psychoses, or substance abuse (including alcohol abuse active within the last 12 months)
- Anyone with a history of intolerance or multiple adverse drug reactions or allergy to (es)citalopram.
- Patients who are currently taking medications active on GABA, including benzodiazepines.
Data sourced from ClinicalTrials.gov (NCT00464711). 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.