Trial Outcomes & Findings for Valproate in Late Life Schizophrenia (NCT NCT00194025)

NCT ID: NCT00194025

Last Updated: 2015-01-06

Results Overview

The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Baseline to 12 weeks

Results posted on

2015-01-06

Participant Flow

The study was conducted at an academic psychiatry clinic in the mid-western United States. Data was collected from participants from February 2004 to November 2006. Participants were recruited in response to self-referrals from advertisements and by referrals from mental health practitioners.

Participant milestones

Participant milestones
Measure	Valproate Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Overall Study STARTED	20
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Valproate Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Overall Study Adverse Event	1
Overall Study non-adherence with study medication	4

Baseline Characteristics

Valproate in Late Life Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Valproate n=20 Participants Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=39 Participants
Age, Categorical >=65 years	5 Participants n=39 Participants
Age, Continuous	61.1 years STANDARD_DEVIATION 9.6 • n=39 Participants
Sex: Female, Male Female	16 Participants n=39 Participants
Sex: Female, Male Male	4 Participants n=39 Participants
Region of Enrollment United States	20 participants n=39 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Last Observation Carried Forward (LOCF) was used as the imputation technique.

The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.

Outcome measures

Outcome measures
Measure	Valproate n=20 Participants Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)	-17.45 scores on a scale Standard Deviation 14.87

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Last Observation Carried Forward (LOCF) was used as the imputation technique.

The best and worst possible overall scores are 31 and 0 units on a scale, respectively.

Outcome measures

Outcome measures
Measure	Valproate n=20 Participants Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)	0.4 scores on a scale Standard Deviation 3.218

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Last Observation Carried Forward (LOCF) was used as the imputation technique.

The best and worst possible GAS scores are 100 and 1 units on a scale, respectively.

Outcome measures

Outcome measures
Measure	Valproate n=20 Participants Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Change in Overall Functioning as Measured by the Global Assessment Scale (GAS)	16.35 scores on a scale Standard Deviation 15.09

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Last Observation Carried Forward (LOCF) was used as the imputation technique.

The best and worst possible GDS scores are 0 and 30 units on a scale, respectively.

Outcome measures

Outcome measures
Measure	Valproate n=18 Participants Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)	-1.556 scores on a scale Standard Deviation 2.502

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: The number of participants for analysis was based on available data. Last Observation Carried Forward (LOCF) was used as the imputation technique.

The best and worst possible MCS scores are 100 and 1 units on a scale, respectively.

Outcome measures

Outcome measures
Measure	Valproate n=14 Participants Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36)	5.298 scores on a scale Standard Deviation 7.968

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Last Observation Carried Forward (LOCF) was used as the imputation technique.

The best and worst possible PCS scores are 100 and 0 units on a scale, respectively.

Outcome measures

Outcome measures
Measure	Valproate n=14 Participants Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36)	0.932 scores on a scale Standard Deviation 5.971

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Last Observation Carried Forward (LOCF) was used as the imputation technique.

The best and worst possible overall scores are 0 and 28 units on a scale, respectively.

Outcome measures

Outcome measures
Measure	Valproate n=19 Participants Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)	-2.105 scores on a scale Standard Deviation 4.108

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Last Observation Carried Forward (LOCF) was used as the imputation technique.

The best and worst possible overall scores are 40 and 0 units on a scale, respectively.

Outcome measures

Outcome measures
Measure	Valproate n=15 Participants Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS)	-0.6 scores on a scale Standard Deviation 1.724

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: All available data was used implementing LOCF.

Outcome measures

Outcome measures
Measure	Valproate n=18 Participants Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Tolerability as Assessed by Weight Change	1.1 kilograms Standard Deviation 3.6

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Last Observation Carried Forward (LOCF) was used as the imputation technique.

Outcome measures

Outcome measures
Measure	Valproate n=20 Participants Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
Tolerability as Measured by Mean Serum Level at Study Endpoint	40.86 ug/mL Standard Deviation 25.29

Adverse Events

Valproate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Martha Sajatovic MD

Case Western Reserve University and Unversity Hospitals Case Medical Center

Phone: 216-844-2808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place