Lamotrigine for Symptoms of Geriatric Bipolar Depression - Study Results

Lamotrigine for Symptoms of Geriatric Bipolar Depression (Geri-BD SAD)

This study has been completed.

Study NCT00621842 Information provided by University Hospitals of Cleveland

First Received on February 12, 2008. Last Updated on September 15, 2011 History of Changes

Results First Received: August 9, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Bipolar Disorder Depression, Bipolar
Interventions:	Drug: Lamotrigine regular tablet formulation Drug: Lamotrigine novel formulation

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began in January 2008 and ended in December 2009. The study screened and enrolled participants at five academic institutions in the United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects were required to have a score of 18 or higher on the Hamilton Rating Scale for Depression 24 to be included in the study.

Reporting Groups

	Description
Open-label Lamotrigine Treatment	This solitary group received open-label lamotrigine treatment for bipolar depression.

Participant Flow: Overall Study

	Open-label Lamotrigine Treatment
STARTED	57
COMPLETED	38
NOT COMPLETED	19
Adverse Event	6
Withdrawal by Subject	7
Protocol Violation	4
Lack of Efficacy	2

Baseline Characteristics

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Reporting Groups

	Description
Open-label Lamotrigine Treatment	This solitary group received open-label lamotrigine treatment for bipolar depression.

Baseline Measures

	Open-label Lamotrigine Treatment
Number of Participants [units: participants]	57
Age [units: participants]
<=18 years	0
Between 18 and 65 years	27
>=65 years	30
Age [units: years] Mean ± Standard Deviation	66.5 ± 6.7
Gender [units: participants]
Female	23
Male	34
Region of Enrollment [units: participants]
United States	57

Outcome Measures

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1. Primary:

Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 weeks ]

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2. Secondary:

Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU) [ Time Frame: 12 weeks ]

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3. Secondary:

Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D) [ Time Frame: 12 weeks ]

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4. Secondary:

Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS) [ Time Frame: 12 weeks ]

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5. Secondary:

Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP [ Time Frame: 12 weeks ]

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6. Secondary:

Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS) [ Time Frame: 12 weeks ]

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7. Secondary:

Change in Body Weight From Baseline [ Time Frame: 12 weeks ]

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8. Secondary:

Number of Participants Who Fell at Least Once During the Study [ Time Frame: 12 weeks ]

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9. Secondary:

Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 12 weeks ]

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10. Secondary:

Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS) [ Time Frame: 12 weeks ]

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11. Secondary:

Number of Participants Who Had a Fall That Required Medical Attention [ Time Frame: 12 weeks ]

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12. Secondary:

Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine [ Time Frame: 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Christopher Bialko
Organization: Case Western Reserve University
phone: 216-286-4362
e-mail: Christopher.Bialko@UHhospitals.org

No publications provided

Responsible Party:	Martha Sajatovic, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00621842 History of Changes
Other Study ID Numbers:	L0971, GSK110720, IND 78,081
Study First Received:	February 12, 2008
Results First Received:	August 9, 2011
Last Updated:	September 15, 2011
Health Authority:	United States: Food and Drug Administration