Trial Outcomes & Findings for Treatment of Schizophrenia With L-tetrahydropalmatine (l-THP): a Novel Dopamine Antagonist With Anti-inflammatory and Antiprotozoal Activity (NCT NCT02118610)

Last Updated: 2022-01-06

Results Overview

Measured by the Brief Psychiatric Rating Scale, positive symptom subfactor, Scale for the Assessment of Negative Symptoms (SANS) and Brief Negative Symptom Scale (BNSS). The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.

Recruitment status

COMPLETED

Study phase

Target enrollment

63 participants

Primary outcome timeframe

Baseline and 4 weeks (endpoint)

Results posted on

2022-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	L-tetrahydropalmatine l-tetrahydropalmatine (30 mg BID) L-tetrahydropalmatine (30mg): Active comparator	Sugar Pill Sugar pill: Placebo
Overall Study STARTED	30	33
Overall Study COMPLETED	29	32
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Schizophrenia With L-tetrahydropalmatine (l-THP): a Novel Dopamine Antagonist With Anti-inflammatory and Antiprotozoal Activity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	L-tetrahydropalmatine n=29 Participants l-tetrahydropalmatine (30 mg BID) L-tetrahydropalmatine (30mg): Active comparator	Sugar Pill n=32 Participants Sugar pill: Placebo	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	32 Participants n=7 Participants	61 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	41.6 years STANDARD_DEVIATION 11.1 • n=5 Participants	41.7 years STANDARD_DEVIATION 10.1 • n=7 Participants	41.65 years STANDARD_DEVIATION 10.52 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	23 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Black	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	32 participants n=7 Participants	61 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks (endpoint)

Outcome measures

Outcome measures
Measure	L-tetrahydropalmatine n=29 Participants l-tetrahydropalmatine (30 mg BID) L-tetrahydropalmatine (30mg): Active comparator	Sugar Pill n=32 Participants Sugar pill: Placebo
Positive and Negative Symptom Improvement Baseline	41.3 score on a scale Standard Deviation 8.8	40.3 score on a scale Standard Deviation 6.9
Positive and Negative Symptom Improvement Endpoint	36.6 score on a scale Standard Deviation 9.0	37.3 score on a scale Standard Deviation 8.7

SECONDARY outcome

Timeframe: Baseline and 4 weeks (endpoint)

Neuropsychological testing will be done at baseline and endpoint using the MATRICS battery. A composite score as well as individual scores will be will be the outcome. This assessment total minimum score of -10 and maximum score of 80. The higher the score the better the outcome.

Outcome measures

Outcome measures
Measure	L-tetrahydropalmatine n=29 Participants l-tetrahydropalmatine (30 mg BID) L-tetrahydropalmatine (30mg): Active comparator	Sugar Pill n=32 Participants Sugar pill: Placebo
Improvement in Cognitive Function Baseline	28.0 score on a scale Standard Deviation 13.9	27.7 score on a scale Standard Deviation 14.1
Improvement in Cognitive Function Endpoint	28.8 score on a scale Standard Deviation 15.1	29.0 score on a scale Standard Deviation 13.7

Adverse Events

L-tetrahydropalmatine

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	L-tetrahydropalmatine n=29 participants at risk l-tetrahydropalmatine (30 mg BID) L-tetrahydropalmatine (30mg): Active comparator	Sugar Pill n=32 participants at risk Sugar pill: Placebo
Blood and lymphatic system disorders Severe Neutropenia	0.00% 0/29 • 4 weeks	3.1% 1/32 • Number of events 1 • 4 weeks

Other adverse events

Other adverse events
Measure	L-tetrahydropalmatine n=29 participants at risk l-tetrahydropalmatine (30 mg BID) L-tetrahydropalmatine (30mg): Active comparator	Sugar Pill n=32 participants at risk Sugar pill: Placebo
General disorders Sedation	31.0% 9/29 • 4 weeks	31.2% 10/32 • 4 weeks
General disorders Headache	31.0% 9/29 • 4 weeks	25.0% 8/32 • 4 weeks
Gastrointestinal disorders Nausea	24.1% 7/29 • 4 weeks	28.1% 9/32 • 4 weeks
Gastrointestinal disorders Diarrhea	20.7% 6/29 • 4 weeks	12.5% 4/32 • 4 weeks
General disorders Dizziness	31.0% 9/29 • 4 weeks	9.4% 3/32 • 4 weeks
General disorders Insomnia	20.7% 6/29 • 4 weeks	25.0% 8/32 • 4 weeks
Gastrointestinal disorders Vomiting	10.3% 3/29 • 4 weeks	15.6% 5/32 • 4 weeks
General disorders Abdominal Pain	10.3% 3/29 • 4 weeks	15.6% 5/32 • 4 weeks
General disorders Constipation	10.3% 3/29 • 4 weeks	15.6% 5/32 • 4 weeks
General disorders Malaise	13.8% 4/29 • 4 weeks	25.0% 8/32 • 4 weeks
General disorders Restlessness	6.9% 2/29 • 4 weeks	21.9% 7/32 • 4 weeks
General disorders Salivation	17.2% 5/29 • 4 weeks	28.1% 9/32 • 4 weeks
General disorders Tinnitus	3.4% 1/29 • 4 weeks	21.9% 7/32 • 4 weeks
General disorders Dry Mouth	13.8% 4/29 • 4 weeks	28.1% 9/32 • 4 weeks

Additional Information

Ann Kearns, MS

Maryland Psychiatric Research Center

Phone: 4104066854

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place