Venlafaxine Versus Lamotrigine in the Treatment of Bipolar I/II Depression

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188643
First received: September 12, 2005
Last updated: February 8, 2011
Last verified: February 2005
  Purpose

The primary objective of this study is to assess the efficacy of venlafaxine XR and lamotrigine when each is added to mood stabilizer therapy in patients with acute depressive episodes of bipolar I or Bipolar II disorder. Efficacy of therapy will be evaluated using improvements in clinical symptomatology after 8 weeks of treatment as measured by reductions on the Hamilton Depression Rating Scale (HDRS-29) total score >50% from baseline. We also would like to assess the efficacy of venlafaxine XR and lamotrigine when each is added to mood stabilizer therapy in improving clinical symptomatology after 8 weeks of therapy as well as to evaluate the side effect profile, safety and tolerability of venlafaxine XR and lamotrigine.


Condition Intervention Phase
Bipolar Disorder
Drug: Venlafaxine and Lamotrigine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-Blind, Acute Depression Study Comparing Venlafaxine XR and Lamotrigine When Added to Mood Stabilizer in the Treatment of Bipolar Depression

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale, 21 item

Secondary Outcome Measures:
  • Young Mania Rating Scale (YMRS)
  • Montgomery Asberg Depression Rating Scale (MADRS)
  • Clinical Global Impression (CGI-I, CGI-S)
  • Quality of Life Enjoyment
  • Global Assessment of Functioning

Estimated Enrollment: 40
Study Start Date: January 2002
Estimated Study Completion Date: January 2007
Detailed Description:

The primary objective of this study is to assess the efficacy of venlafaxine XR and lamotrigine when each is added to mood stabilizer therapy in patients with acute depressive episodes of bipolar I or Bipolar II disorder. Efficacy of therapy will be evaluated using improvements in clinical symptomatology after 8 weeks of treatment as measured by reductions on the Hamilton Depression Rating Scale (HDRS-29) total score >50% from baseline. We also would like to assess the efficacy of venlafaxine XR and lamotrigine when each is added to mood stabilizer therapy in improving clinical symptomatology after 8 weeks of therapy as well as to evaluate the side effect profile, safety and tolerability of venlafaxine XR and lamotrigine.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Meets DSM-IV criteria for a diagnosis of Bipolar I disorder, most recent episode depression, or bipolar II disorder, most recent episode depression using the structured clinical interview for DSM-IV Axis 1 disorders 2. Subjects must have a Hamilton depression rating scale score of >16. 3. Patients at visit 1 must have documented trials (levels must be obtained) of their mood stabilizer for at least 2 weeks 4. Subjects must be between the ages of 18-70, male or female 5. Treatment with oral antipsychotics, anticonvulsants or benzodiazepines prior to enrolment or during the study will be permitted, but not other antidepressants.

    6. Female patients of childbearing potential must be using a medically accepted means of contraception.

    7. Patient is judged by the investigator to be in generally good health 8. Education level and a degree of understanding is such that the patient can communicate effectively with the investigator.

    9. Patient must be capable of providing informed consent.

Exclusion Criteria:

  • 1. Treatment with antidepressant medication within one day prior to visit 1 or during the protocol.

    2. Patients previously showing poor therapeutic response to venlafaxine XR or lamotrigine 3. Judged clinically to be at serious suicidal risk. 4. DSM-IV criteria for substance dependence (except nicotine or caffeine) within the past 30 days 5. Course of ECT (electroconvulsive therapy) in the preceding 4 weeks prior to visit 1 or during the protocol.

    6. Patients who suffer from a major neurological or medical illness. 7. Current diagnosis of schizophrenia or other psychotic disorders as defined in the DSM-IV 8. Uncorrected hypothyroidism or hyperthyroidism 9. Female patients who are either pregnant or nursing 10. Elevated thyroid stimulating hormone (TSH).

  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: NCT00188643

Locations
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Roger McIntyre, MD,FRCPC University Health Network, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00188643     History of Changes
Other Study ID Numbers: 001
Study First Received: September 12, 2005
Last Updated: February 8, 2011
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Bipolar Disorder, Depression, Anticonvulsants, Antidepressants

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Lamotrigine
Anticonvulsants
Venlafaxine
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 20, 2014