Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms

Columbia Northwest Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder; Depression Not Otherwise Specified; Borderline Personality Disorder; Dysthymia

Treatments: Drug: Lithium Carbonate; Drug: Citalopram; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01189812

LP-DP-09201

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

sugar pill

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Citalopram

Lithium

Active Comparator group

Treatment:

Drug: Citalopram

Drug: Lithium Carbonate