Lamotrigine and Venlafaxine and Lamotrigine in Bipolar Disorder - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Bipolar Disorder

Intervention / Treatment

Drug: Venlafaxine and Lamotrigine

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.

Study Type

Interventional

Enrollment

40

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Toronto, Ontario, Canada, M5T2S8
    - Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Hamilton Depression Rating Scale, 21 item

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

Principal Investigator: Roger McIntyre, MD,FRCPC, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria