Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00562861
First received: November 20, 2007
Last updated: February 21, 2017
Last verified: February 2017
  Purpose

Bipolar depression is one of the least studied depressive illnesses. The standard practice for many doctors is to use antidepressant medicines, but there are few studies on the long-term results of these medicines. The goal of this study is to look at how effective and safe these medicines are in treating bipolar depression when taken with a mood stabilizer medicine.

The drug being studied is citalopram, also known as Celexa. Celexa is FDA approved for the treatment of major depression, but is not FDA approved for the treatment of bipolar depression. It is, however, standard practice for many doctors is to use antidepressants, like Celexa, to treat their patients with bipolar disorder depression.

The drug will be studied in three ways. We will see if it helps treat depressive symptoms. We will see how the drug affects the brain using PET and fMRI scans. Finally, we will look at the possibility that there may be a gene that could predict if a person would get better taking the drug using genetics.


Condition Intervention Phase
Bipolar Disorder
Bipolar Depression
Drug: citalopram + mood stabilizer
Drug: placebo + mood stabilizer
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • MADRS Rating Scale Change [ Time Frame: 6 weeks ]
    Montgomery Asberg Depression Rating scale assessed in mixed effects regression model. The total range for the scale is 0 to 60. Lower values involve less depression, while higher values involve worse depression. The change in the MADRS scale is interpreted as higher values meaning better outcomes, because more depressive symptoms are improved.


Enrollment: 119
Study Start Date: November 2007
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: citalopram + mood stabilizer
All patients are on baseline mood stabilizers and are randomized to receive citalopram or placebo. In this arm, they are randomly assigned to citalopram.
Drug: citalopram + mood stabilizer
Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d. No target dose will be provided but rather clinicians will dose to clinical efficacy. Thus the study will provide clinicians data on the effective dose if it is positive. The dose will not be predetermined at static amounts.
Other Name: Celexa
Placebo Comparator: placebo + mood stabilizer
All patients are on baseline mood stabilizers and are randomized to receive citalopram or placebo. In this arm, they are randomly assigned to placebo
Drug: placebo + mood stabilizer
This arm will only receive mood stabilizing medication. All subjects will be required to receive treatment with lithium, lamotrigine, valproate, or carbamazepine for at least one month at therapeutic blood levels or doses before randomization, or they must initiate one of these agents at study entry.
Other Name: lithium, lamotrigine, valproate, or carbamazepine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current age ≥18 years
  • DSM-IV diagnosis of BPD, type-I, or type-II
  • Current major depressive episode using DSM-IV criteria, lasting 8 weeks or longer.
  • Use of lithium, divalproex, carbamazepine, or lamotrigine at therapeutic serum levels or doses for ≥4 weeks prior to study entry, or willingness to accept one of these agents.
  • Prior to initial evaluations, each subject must provide competent, written, informed consent.

Exclusion Criteria:

  • Past non-response to a therapeutic trial of R,S-citalopram (≥100 mg/day for ≥8 weeks).
  • Previous intolerance of R,S-citalopram;
  • Diagnosis of unipolar depression
  • Diagnosis of schizoaffective disorder
  • Serious medical illness with acute instability (cardiac, respiratory, hepatic, renal), based on hospitalization in the past month
  • Abnormal thyroid function tests
  • Previous allergic reaction to or inability to tolerate lithium, divalproex, or carbamazepine at therapeutic serum levels.
  • Current or past renal dysfunction if taking lithium
  • Current or past hepatitis or other liver disease if taking divalproex
  • Current or past hematologic disease if on carbamazepine
  • Severe suicidal ideation, plan or intent, as documented by a score of ≥4 on the Montgomery Åsberg Depression Rating Scale suicidality item (Item 10).
  • Presence of psychosis
  • Cognitive impairment sufficient to impair ability to give informed consent.
  • Current pregnancy, or inability to utilize contraception
  • The presence of any metallic implants
  • History of claustrophobia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562861

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Tufts Medical Center
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Nassir Ghaemi, MD, MPH Tufts University Medical
  More Information

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00562861     History of Changes
Other Study ID Numbers: MH78060-01A1
5R01MH078060-04 ( US NIH Grant/Contract Award Number )
Study First Received: November 20, 2007
Results First Received: July 7, 2016
Last Updated: February 21, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Tufts Medical Center:
Bipolar Disorder
Bipolar Depression
Clinical Trials, Phase II
Clinical Pharmacology

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Citalopram
Lamotrigine
Dexetimide
Valproic Acid
Carbamazepine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 24, 2017