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

Information source: Columbia Northwest Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder; Dysthymia; Depression Not Otherwise Specified; Borderline Personality Disorder

Intervention: Lithium Carbonate (Drug); Placebo (Drug); Citalopram (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Columbia Northwest Pharmaceuticals

Official(s) and/or principal investigator(s):
Arifulla Khan, MD, Principal Investigator, Affiliation: Northwest Clinical Research Center
Vishaal Mehra, MD, Principal Investigator, Affiliation: Aretmis Institute for Clinical Research

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.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Assess the Safety and Efficacy of Citalopram in Combination With Lithium or Placebo in the Treatment of Symptoms in Patients With Depressive Mood Disorders

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Sheehan-Suicidality Tracking Scale (S-STS)

Secondary outcome:

Beck Hopelessness Scale (BHS)

Beck Scale for Suicide Ideation (BSS)

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Artemis Institute for Clinical Research, San Diego, California 92123, United States

Northwest Clinical Research Center, Bellevue, Washington 98007, United States

Additional Information

Starting date: March 2010
Last updated: August 22, 2011

Page last updated: August 23, 2015

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