Phase 2
Completed N=80
Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms
Major Depressive Disorder · Dysthymia · Depression Not Otherwise Specified · borderline personality disorder
Source: ClinicalTrials.gov NCT01189812 ↗
Enrolled (actual)
80
Serious AEs
2.5%
Results posted
Jun 2011
Primary outcomePrimary: Sheehan-Suicidality Tracking Scale (S-STS) — 4.8; 5.0 Scores on a Scale (S-STSS)
Summary
The investigators hypothesize that patients receiving citalopram in combination with lithium will have a greater reduction in depressive symptoms than patients receiving citalopram in combination with placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sheehan-Suicidality Tracking Scale (S-STS) |
4.8; 5.0 | — |
| SECONDARY Beck Hopelessness Scale (BHS) |
— | — |
| SECONDARY Beck Scale for Suicide Ideation (BSS) |
— | — |
Eligibility Criteria
Inclusion Criteria
- 18-75 years of age
- Meets criteria for Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified or Borderline Personality Disorder
- Ability to speak, read and understand the English Language and provide written informed consent
Exclusion Criteria
- Current, unstable and significant medical condition or illness
- History of Thyroid disorder, seizure disorder, tumors or other CNS condition that predisposes the patient to risk of seizure
- Pregnant or lactating females
- Abnormal clinical laboratory test results
- Intolerance or hypersensitivity to SSRIs or lithium
- History or current diagnosis of bipolar mood disorder, psychosis, schizophrenia or dementia
- Certain mediations my not be used prior or during the study
Data sourced from ClinicalTrials.gov (NCT01189812). 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.