Lamotrigine for Symptoms of Geriatric Bipolar Depression (Geri-BD SAD)
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ClinicalTrials.gov Identifier: NCT00621842 |
Recruitment Status :
Completed
First Posted : February 22, 2008
Results First Posted : October 25, 2011
Last Update Posted : December 30, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar Disorder Depression, Bipolar | Drug: Lamotrigine regular tablet formulation Drug: Lamotrigine novel formulation | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 57 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-label, Prospective Trial of Lamotrigine for Symptoms of Geriatric Bipolar Depression |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Open-Label Lamotrigine Treatment |
Drug: Lamotrigine regular tablet formulation
Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds.
Other Name: Lamictal Drug: Lamotrigine novel formulation Participants will have the option of trying a novel formulation of lamotrigine tablets instead of the lamotrigine regular formulation tablets. The dosing will remain the same regardless of which type of lamotrigine tablet is used. Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds. Other Name: Lamictal |
- Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 weeks ]The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
- Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) [ Time Frame: 12 weeks ]Frequency of adverse effects was measured using the UKU. The total number of adverse effects assessed by the UKU is 49 plus one open-ended question about any adverse effects not assessed.
- Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D) [ Time Frame: 12 weeks ]The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition.
- Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS) [ Time Frame: 12 weeks ]The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
- Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP [ Time Frame: 12 weeks ]The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
- Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS) [ Time Frame: 12 weeks ]The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.
- Change in Body Weight From Baseline [ Time Frame: 12 weeks ]
- Number of Participants Who Fell at Least Once During the Study [ Time Frame: 12 weeks ]
- Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 12 weeks ]The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.
- Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS) [ Time Frame: 12 weeks ]The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition.
- Number of Participants Who Had a Fall That Required Medical Attention [ Time Frame: 12 weeks ]
- Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 60 Years or older
- BP Disorder-I or II: Depressive episode (DSM -IV-TR; SCID-I/P)
- HAM-D score > 18 (GRID-HAM-D 24-item version)
- Availability of an Informant is encouraged but not required for study participation
Exclusion Criteria:
- Chronic psychotic conditions, ie. schizophrenia, schizoaffective disorder, delusional disorder
- Contraindication to lamotrigine (Physician interview, medical assessment)
- Documented history of intolerance to lamotrigine
- Patients who have previously failed to respond to at least 12 weeks of treatment with lamotrigine
- Active substance dependence (SCID-I/P) or substance-related safety issues or PI concerns
- Mood Disorder Due to a General Medical Condition or Treatment (Physician interview)
- Rapid cycling (Physician interview): As defined in DSM-IV: At least 4 episodes of mood disturbance in the previous 12 months that meet criteria for a Major Depressive, Manic, Mixed or Hypomanic Episode. Episodes are distinguished either by partial or full remission for at least 2 months or by a switch to an episode of opposite polarity
- Dementia (by DSM-IV or brain degenerative diseases; Physician interview);
- Inability to communicate in English (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in English)
- Clinically significant sensory impairment (i.e., cannot see well enough to read consent or visually-presented material; cannot hear well enough to cooperate with interview; Physician interview)
- Recent history of cardiovascular, peripheral vascular events or stroke
- High risk for suicide (e.g., active SI or current intent or plan)
- Inpatient status

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621842
United States, New York | |
Weill Medical College of Cornell University | |
White Plains, New York, United States, 10605 | |
United States, Ohio | |
University Hospitals Case Medical Center/ Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
Baylor College of Medicine/Michael E. DeBakey VAMC | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Martha Sajatovic, MD | Case Western Reserve University School of Medicine |
Responsible Party: | Martha Sajatovic, Professor of Psychiatry, University Hospitals Cleveland Medical Center |
ClinicalTrials.gov Identifier: | NCT00621842 |
Other Study ID Numbers: |
L0971 GSK110720 IND 78,081 ( Other Identifier: FDA ) |
First Posted: | February 22, 2008 Key Record Dates |
Results First Posted: | October 25, 2011 |
Last Update Posted: | December 30, 2014 |
Last Verified: | December 2014 |
Geriatric Psychiatry Aged lamotrigine |
Depression Depressive Disorder Bipolar Disorder Behavioral Symptoms Mood Disorders Mental Disorders Bipolar and Related Disorders Lamotrigine Anticonvulsants Calcium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Sodium Channel Blockers |