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

NCT01189812 | Completed Phase 2 Results

• 1 other identifier: LP-DP-09201
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

hopelessness; alone; sad; troubled; depression

Outcome Measures

Primary Outcomes (1)

• Sheehan-Suicidality Tracking Scale (S-STS)

  The S-STS is an 14 item clinician administered prospective rating scale that scores both treatment-emergent suicidal ideations and suicidal behaviors with scores ranging from 0-40 points. Patients scoring a 0 are experiencing no suicidal thoughts, ideations, or attempts, while a score of 40 indicates a fatal, completed suicide. Comparison was made between the citalopram with lithium and the citalopram with placebo treatment groups. Outcome measures are expressed as change scores from the baseline visit to week 4.

  4 weeks; from Baseline to Week 4

Secondary Outcomes (2)

• Beck Hopelessness Scale (BHS)

  4 weeks

• Beck Scale for Suicide Ideation (BSS)

  4 weeks

Study Arms (2)

sugar pill

PLACEBO COMPARATOR

Drug: Placebo; Drug: Citalopram

Lithium

ACTIVE COMPARATOR

Drug: Lithium Carbonate; Drug: Citalopram

Interventions

Lithium Carbonate DRUG

300 mg one time per day for 4 weeks

Lithium

Placebo DRUG

Take one time daily for 4 weeks

sugar pill

Citalopram DRUG

All patients will be administered Citalopram 20 mg to to be taken once daily, by mouth for the duration of the double-blind treatment phase (4 weeks)

Also known as: Celexa

Lithium; sugar pill

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia Northwest Pharmaceuticals: lead

Study Sites (2)

Artemis Institute for Clinical Research

San Diego, California, 92123, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Dysthymic Disorder; Borderline Personality Disorder; Depression

Interventions

Lithium Carbonate; Citalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Personality Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Columbia Northwest Pharmaceuticals

jhobus@nwcrc.net

425.453.0404

Study Officials

• Arifulla Khan, MD

  Northwest Clinical Research Center

  PRINCIPAL INVESTIGATOR

• Vishaal Mehra, MD

  Aretmis Institute for Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: August 27, 2010
• Study Start: March 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 24, 2011
• Results First Posted: June 8, 2011

Record last verified: 2011-08

Locations

US (2)